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FDA Releases CRLs for Previous Drug and Biologic Product Applications
The FDA has published an initial batch of 202 complete response letters (CRLs)—many of which were issued in response to applications submitted to the FDA between 2020 and 2024—that were seeking the approval of drugs or biologic products.¹

Notably, 32 of the published CRLs were issued in response to submissions seeking the approval of oncology-related treatments and products.

The initial set of published decision letters is composed of those addressing deficiencies in since-approved applications, and is now accessible to the public at open.fda.gov. Parts of these CRLs have been redacted to protect confidential commercial information and trade secrets. The FDA plans to publish additional CRLs from its archives.

The publication of these CRLs reflects the FDA’s broader efforts to increase transparency surrounding the administration’s decision-making process, according to a news release from the FDA. The availability of these letters also gives the public greater insight into some of the most common deficiencies that the FDA cites for product sponsors to address before their product applications may be approved.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” Marty Makary, MD, MPH, FDA Commissioner, stated in the news release. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

The FDA issues CRLs directly to product sponsors after completing the review process and determining that it cannot approve an application in its present form. CRLs may be issued for a variety of reasons, including safety concerns, efficacy concerns, bioequivalence issues, and manufacturing deficiencies. The specific reasons for each CRL are detailed in the letters, which may also include recommendations for addressing these deficiencies.

Historically, the FDA has not routinely published CRLs that have been issued for pending applications, which has led to discrepancies between the FDA’s rationales for its decisions and the sponsors’ representations of this decision-making to stakeholders and the public. For example, an analysis conducted by FDA researchers in 2015 revealed that in public announcements sharing that their product applications were not FDA approved, sponsors did not mention 85% of the FDA’s concerns regarding safety and efficacy. Furthermore, the study found that approximately 40% of CRL announcements by sponsors did not disclose when the FDA recommended the initiation of a new clinical trial for safety- or efficacy-related reasons. Additionally, there is a lack of disclosed explanations about the issuance of CRLs within the drug development industry, leading sponsors to repeat similar mistakes.

Notable CRLs in the initial published batch include those regarding the applications seeking the approvals of:
- Sodium thiosulfate (Pedmark) for the prevention of cisplatin-related ototoxicity in pediatric patients at least 1 month of age with localized, nonmetastatic solid tumors (August 2020)²; this agent was later FDA approved for this indication in September 2022.³
- Toripalimab-tpzi (Loqtorzi) plus gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, as well as toripalimab monotherapy for the second-line and later treatment of patients with recurrent or metastatic disease (May 2022)⁴; these regimens were later FDA approved for their respective indications in October 2023.⁵
- Denileukin diftitox-cxdl (Lymphir) for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma (July 2023)⁶; this agent was later FDA approved for this indication in August 2024.⁷
- Zolbetuximab-clzb (Vyloy) for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive (January 2024)⁸; this agent was later FDA approved in combination with chemotherapy for this indication in October 2024.⁹
References
1. FDA embraces radical transparency by publishing complete response letters. FDA. July 10, 2025. Accessed July 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters?utm_medium=email&utm_source=govdelivery
2. FDA. Complete Response Letter for NDA 212937, Fennec Pharmaceuticals, Inc. Accessed July 20, 2025. https://open.fda.gov/apis/other/approved_CRLs/
3. FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors. FDA. Updated March 14, 2024. Accessed July 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sodium-thiosulfate-reduce-risk-ototoxicity-associated-cisplatin-pediatric-patients
4. FDA. Complete Response Letter for BLA 761240, Coherus BioSciences, Inc. Accessed July 10, 2025. https://open.fda.gov/apis/other/approved_CRLs/
5. Coherus and Junshi Biosciences announce FDA approval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Coherus BioSciences and Shanghai Junshi Biosciences. October 27, 2023. Accessed July 10, 2025. https://www.globenewswire.com/news-release/2023/10/27/2768663/0/en/Coherus-and-Junshi-Biosciences-Announce-FDA-Approval-of-LOQTORZI-toripalimab-tpzi-in-All-Lines-of-Treatment-for-Recurrent-or-Metastatic-Nasopharyngeal-Carcinoma-NPC.html
6. FDA. Complete Response Letter for BLA 761312, Citius Pharmaceuticals, Inc. Accessed July 10, 2025. https://open.fda.gov/apis/other/approved_CRLs/
7. Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma. News release. Citius Pharmaceuticals. August 8, 2024. Accessed July 10, 2025. https://citiuspharma.com/investors/news-media/news/release-details/2024/Citius-Pharmaceuticals-Receives-FDA-Approval-for-LYMPHIR-denileukin-diftitox-cxdl-Immunotherapy-for-the-Treatment-of-Adults-with-Relapsed-or-Refractory-Cutaneous-T-Cell-Lymphoma/default.aspx
8. FDA. Complete Response Letter for BLA 761365, Astellas Pharma US, Inc. Accessed July 10, 2025. https://open.fda.gov/apis/other/approved_CRLs/
9. FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma. FDA. October 18, 2024. Accessed July 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma
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July 10, 2025
The official Fantastic Four: First Steps tie-in comic has revealed the first look at another of the movie's supervillains – GamesRadar+
1. The official Fantastic Four: First Steps tie-in comic has revealed the first look at another of the movie’s supervillains GamesRadar+
2. Marvel Rundown: Leave FANTASTIC FOUR #1 stranded ComicsBeat
3. Fantastic Four’s Invisible Woman Reveals Just How Powerful She Truly Is Yahoo News
4. ‘Fantastic Four: First Steps’ Has Revealed Its Take on Mole Man Gizmodo
5. MCU’s Fantastic Four Comic Reveals How First Steps Changes Their Origin SuperHeroHype
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July 10, 2025
Scientists simulate what the first days of early Earth were really like

Earth started out as a ball of liquid fire, its newborn surface closer to a lava lamp than the calm continents we know today. Those incandescent beginnings happened 4.5 billion years ago, yet the evidence is buried miles beneath our feet where direct sampling is impossible.

A new computer model of the infant planet’s mantle says the rock we stand on still remembers that fiery youth, right down to the chemical fingerprints laid down within the planet’s first hundred million years.

Assistant Professor Charles‑Édouard Boukaré, Department of Physics and Astronomy, York University, led the new study.

Early Earth was a molten world

When the young Earth cooled, it did not freeze evenly like a lake in winter. It simmered from the top down and the bottom up at the same time, leaving pockets of melt trapped deep inside.

Planetary scientists call that global melt a basal magma ocean, a deep layer of iron‑rich liquid pooling just above the metal core, and its existence explains why the modern core still loses heat so slowly.

Seismic scans of the modern deep mantle reveal sprawling ultralow velocity zones that slow earthquake waves, hinting they contain that same dense, iron‑heavy melt and supporting the basal ocean concept.

These reservoirs sit beneath the Pacific and Africa today, covering areas wider than the continental United States, yet they are hard to image because they lie nearly eighteen hundred miles down.

Exactly when those structures formed has been uncertain because many earlier simulations treated the mantle as a single gooey fluid, erasing the complex dance between liquid and crystal that governs segregation.

Modeling magma to solid rock

The code named Bambari by the researchers divided Earth’s interior into a fine grid and began with a half‑melted mantle, about fifty percent liquid, a state thought to be realistic after the giant impact that created the Moon.

Temperature contrasts made lighter crystal mush rise while heavier, iron‑loaded droplets sank, all as heat bled into cold space, and the model resolved motions at scales from global overturns to turbulent eddies only a few miles across.

Within a few thousand simulated years the top hundred miles had cooled enough for crystals to lock together, forming down‑plunging sheets that ferried a shallow chemical signal into the deep, a result that surprised the research team.

More crystals formed near the surface than near the core, overturning the textbook view that solidification begins at depth, and the outcome hints that early Earth might have sported a short‑lived rocky crust that repeatedly sank back into the mantle.

Because the falling crystals reheated and partly melted on the way down, they left behind an iron‑rich brew that eventually puddled into an ocean of liquid rock roughly three hundred miles thick above the core, one that may have persisted for half a billion years and acted as a blanket trapping core heat.

Surprising chemistry on early Earth

Low‑pressure minerals such as olivine were expected to dominate only the upper mantle, yet Boukaré’s run shows their fingerprints nearly twelve‑hundred miles below.

This finding that forces a rethink of how trace elements were sorted. The reason is mechanical: surface‑grown crystals fell like hailstones, skipping equilibrium reactions at depth.

As they sank, mass balance pumped iron‑rich melt upward where it chilled, creating downwellings enriched in trace elements such as samarium and neodymium, and the pattern repeated until the mantle became mostly solid.

That process stamped unusual Lu/Hf and Sm/Nd ratios that still appear in 3.8 billion‑year‑old rocks from Greenland, offering a rare chemical time capsule of early differentiation.

“This study is the first to demonstrate that the first‑order features of Earth’s lower mantle structure were established four billion years ago,” said Boukaré.

Remnants in Earth’s mantle today

The simulation naturally birthed the two giant “superplumes,” formally known as large low shear‑velocity provinces or LLSVPs, that sit under the Pacific and Africa and rise more than six‑hundred miles off the core.

In the model they form as the dregs of the magma ocean, loaded with iron and slightly radioactive elements that keep them hotter than their surroundings, an explanation that unifies decades of seismic and geochemical hints.

That extra heat helps feed volcanic hotspots such as Hawaii and Iceland, linking events separated by billions of years through persistent mantle circulation.

High‑precision noble‑gas measurements in ocean‑island basalts point to ancient, undegassed mantle domains that match the predicted reservoirs, giving independent support to the model’s deep‑time narrative.

Because the model reproduces both seismic and chemical observations, it knits together disciplines that rarely intersect and offers a single story for the planet’s deep past.

What this means for other planets

The equations behind Bambari apply to any rocky world, big or small, making the tool valuable far beyond Earth studies.

For Mars, whose lower mass bleeds heat faster, the basal magma ocean would have frozen early, starving the core of insulation and hastening the loss of its magnetic shield within a few hundred million years, a scenario that dovetails with rover data showing weak residual magnetism in surface rocks.

For a super‑Earth twice our planet’s size, the same physics predicts a magma ocean that could linger a billion years, sustaining a long‑lived dynamo and perhaps protecting an atmosphere long enough for life to emerge.

“If we know some kind of starting conditions, and we know the main processes of planetary evolution, we can predict how planets will evolve,” Boukaré explained. That prospect gives exoplanet hunters a fresh tool for judging habitability without leaving the telescope.

The study is published in Nature.

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July 10, 2025
A Case of Behçet’s Disease Initially Presenting With Acute Dyspnea Due to Subglottitis

Specialty

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July 10, 2025
FDA Approves BRAVECTO® QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health

July 10, 2025 4:46 pm ET

12-Month Parasiticide Treatment for Dogs Offers Unrivaled Duration of Flea and Tick Protection Compared to Existing Products

RAHWAY, N.J., July 10, 2025 – Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) – a new, once-yearly1 injectable product to treat and protect dogs from fleas and ticks. The product is expected to be available at veterinary clinics and hospitals nationwide by August 2025.

BRAVECTO QUANTUM was first approved in Australia and New Zealand in 2023, followed by the European Union (EU) in 2024 and now the U.S. in 2025. In total, BRAVECTO QUANTUM is currently approved in more than 50 countries worldwide.

“We take great pride in our company’s leadership in long-acting preventative parasiticides and are excited to offer a convenient option that gives dogs year-round1 comprehensive protection from fleas and ticks in one easy injection they can receive from their veterinarian,” said Christine Royal, DVM, vice president, companion animal and equine business unit, Merck Animal Health. “The approval of BRAVECTO QUANTUM sets a new standard in pet care by providing veterinarians and pet parents with a safe and effective option when it comes to flea and tick protection for dogs.”

BRAVECTO QUANTUM kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations – Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick) for 12 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older.

BRAVECTO QUANTUM is the first and only parasiticide that protects against fleas and ticks for an entire year with a single dose, offering longer flea and tick protection than any other systemic product currently on the market.

“Though people often think of flea and tick season during the summer months, studies have shown that while fleas and ticks are most active from early spring through the fall, they can be a threat year-round, especially knowing it only takes a few warm days for ticks to become active,” said Frank Guerino, Ph.D., associate vice president of Global Pharmaceutical Development, Merck Animal Health. “With BRAVECTO QUANTUM, a single dose provides year-long, continuous protection, simplifying care for both pet owners and veterinarians, and promoting compliance.”

BRAVECTO QUANTUM utilizes a unique, patented composition of fluralaner that allows effective levels to be maintained for as long as 12 months. Fleas and ticks are a nuisance and pose serious risk to both animal and human health as they can transmit serious diseases. Fleas can also cause severe allergic dermatitis in dogs and cats. Many fleas and ticks can live in both warm and cold temperatures, making continuous year-round protection of utmost importance for pets and people.

BRAVECTO QUANTUM exemplifies Merck Animal Health’s commitment to groundbreaking science and has been recognized as a winner of the 2024 Edison Awards and the 2024 S&P Global Awards for Best New Companion Animal Product. For more information, visit us.bravecto.com or follow BRAVECTO on Instagram @bravecto.us.

¹ BRAVECTO® QUANTUM is indicated to protect against Amblyomma americanum for 8 months.

About BRAVECTO®

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 350 million doses distributed in 100 countries over eight years. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

The flea lifecycle can last as long as 12 weeks, and monthly treatments may leave gaps in protection. Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet owners, fleas and ticks are not only active in the spring and summer months and are a year-round risk. Fleas and ticks can easily latch onto dogs and cats and can spread serious diseases. Fleas are the most common external parasite found on pets. BRAVECTO products are only available through licensed veterinarians.

Important Safety Information

BRAVECTO QUANTUM: indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and for the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick) and Rhipicephalus sanguineus (brown dog tick)] for 12 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 months in dogs and puppies 6 months of age and older. BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) for Dogs: The most commonly reported adverse reactions in a US field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes and pruritus. BRAVECTO QUANTUM is not effective against lone star ticks beyond 8 months of dosing. Fluralaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safety of BRAVECTO QUANTUM has not been evaluated in breeding, pregnant and lactating dogs. In some cases, adverse events have been reported following use of BRAVECTO (fluralaner) Chews in breeding females. For use in dogs and puppies 6 months of age and older.

BRAVECTO 1-MONTH Chews: indicated for dogs 8 weeks of age and older. The most commonly reported adverse reactions include itching, diarrhea, vomiting, decreased appetite, elevated ALT, lethargy, and weight loss. BRAVECTO 1-MONTH is not effective against A. americanum in puppies less than 6 months of age. BRAVECTO Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO Topical Solution for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. BRAVECTO Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO PLUS Topical Solution for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated.

BRAVECTO has not been shown to be effective for 12-weeks’ duration in puppies or kittens less than 6 months of age. BRAVECTO Chews and Topical Solution for dogs is not effective against the lone star tick beyond 8 weeks of dosing. BRAVECTO Topical Solution for Dogs and Cats and BRAVECTO PLUS for cats are for topical use only. Avoid oral ingestion.

The safety of BRAVECTO Topical Solution for Cats and BRAVECTO PLUS has not been established in breeding, pregnant, and lactating cats.

All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.

About Merck Animal Health

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals^®, Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contact:

Laurel Sawicki

(908) 872-9783

laurel.mundth@merck.com

Kim Gorode

(973) 255-9094

Kim.gorode@merck.com

Investor Inquiries:

Peter Dannenbaum

(908) 740-1037

peter.dannenbaum@merck.com

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July 10, 2025
Mpox cases rise in handful of Africa’s outbreak countries

Though cases are falling in two of the region’s high-burden countries, officials from the Africa Centres for Disease Control and Prevention (Africa CDC) are tracking rises in several other nations, including Burundi, Uganda, Ghana, Kenya, Liberia, and Guinea, a top official said today.

At the agency’s weekly briefing, Yap Boum, PhD, MPH, deputy incident manager for Africa CDC’s mpox response, said 23 African countries have reported outbreaks this year, and 18 of them are still active. He emphasized that outbreak dynamics vary by country, reflecting differences in clades, affected populations, outbreak measures, and health behaviors.

Cases have been steadily declining in Sierra Leone—where community healthcare workers are making headway with contact tracing and vaccination—and in the Democratic Republic of the Congo (DRC). Boum added that health workers in several countries face the challenge of measles outbreaks occurring alongside mpox circulation, with diseases initially having similar symptoms. Infections in the DRC, Uganda, and Sierra Leone made up 74% of all cases in Africa last week, a proportion that has dropped as cases rise in other affected nations.

He said Sierra Leone has made strong progress with mpox vaccination, with more than 120,000 people immunized so far, but vaccine shortages now limit expansion to other high-burden countries.

Resurgence in Burundi, Uganda

Resurgence in Burundi, which saw early success after emerging as one of the continent’s hot spots, is partly related to public perception that the outbreak is over, Baum said, adding that more risk communication efforts are needed to counteract that message. He also said stepped-up surveillance is needed to track down all chains of transmission.

Circulation is occurring in 7 of Burundi’s 46 districts, especially in Bujumbura North.

Uganda, also experiencing resurgence, reported a 60% rise in cases last week. Kampala reported about half of the cases, which partly reflects increased active surveillance. Boum said outbreaks are also flaring in Wakiso and Masaka City.

Rises in more recently affected countries

Elsewhere, Ghana reported a doubling of cases in the last reporting week, which he said is quite concerning. As in other West African countries, clade 2 is circulating. Ghana’s Western Region is most affected, making up 54.6% of all confirmed cases.

Kenya reported its highest weekly total since its outbreak began last summer, as responders face challenges in tracking cases in the community. Boum said circulation of the virus in Kenya has now moved beyond the northern transport corridor, where most of the infections involved truck drivers, sex workers, and businesspeople, which signifies wider community transmission.

Elsewhere, Liberia has reported an upward trend over the past 2 weeks, with 43% of cases in Montserrado. Test positivity is up sharply, from 37% to 79% over the past 2 weeks. Similarly, Guinea has reported rising cases over the past 4 weeks, with most of the confirmed cases in Conakry and Kindia regions.

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July 10, 2025
Vietnam thought it had a deal on its US tariff rate. Then Trump stepped in. – Politico

Vietnam thought it had a deal on its US tariff rate. Then Trump stepped in.  Politico

China treads a fine line with its trade warning  TradingView

Will the US Vietnam deal on tariffs enable further acceleration of the country’s wood industry  Fordaq

U.S.-Vietnam Trade Deal Has Serious Implications for Southeast Asia  Asia Society

Tariff deal with US lifts high-flying Vietnamese air cargo demand  Journal of Commerce

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July 10, 2025
[Galaxy Unpacked 2025] The Next Chapter in Personalized, Multimodal Galaxy Innovation – Samsung Mobile Press

▲ Galaxy Unpacked 2025 took place at Duggal Greenhouse in Brooklyn.

On July 9, Samsung Electronics hosted Galaxy Unpacked 2025 in Brooklyn — a borough known for its culture, creativity and spirit of collaboration. Under the theme of “Unfold Ultra,” the event reimagined what’s possible in the era of mobile AI. The all-new Galaxy Z Fold7, Galaxy Z Flip7, Galaxy Z Flip7 FE and Galaxy Watch8 series showcased seamless integration of Galaxy AI, redefined form factors and transformative performance.

Samsung Newsroom was on the ground at Galaxy Unpacked 2025, where the next chapter of mobile AI innovation unfolded.

▲ Roh opens the showcase by boldly announcing a new direction for Galaxy AI.

Building on a legacy of human-centered innovation, Samsung’s latest lineup reflects a clear vision — making AI more meaningful, personal and accessible. From slimmer foldables to personalized health-tracking wearables, these devices chart a bold trajectory for how AI companions can support users in every moment.

▲ Roh shares the vision for Galaxy AI as a true AI companion.

“When AI is paired with powerful mobile technology, it opens up a whole new world of opportunities,” said TM Roh, President, Acting Head of Device eXperience (DX) Division and Head of Mobile eXperience (MX) Business at Samsung Electronics. “The biggest breakthroughs are made when hardware, software and services challenge each other to grow.”

▲ The Galaxy Z Fold7 and Galaxy Z Flip7 are revealed through a launch video.

One UI 8: Made for Foldables, Powered by AI

▲ Won-Joon Choi, Chief Operating Officer of Mobile eXperience (MX) Business at Samsung Electronics, introduces One UI 8.

At the center of this transformation is One UI 8 — Samsung’s next-generation interface designed specifically for foldables, optimized for AI and built on the principles of multimodal understanding and deep personalization.

Privacy and security are core to One UI 8. The on-device Personal Data Engine learns from user preferences, while Knox Enhanced Encrypted Protection secures and isolates information within the app where it’s used.

Android 16 is available on the Galaxy Z Fold7 and Galaxy Z Flip7 at launch — made possible through close collaboration with Google.

▲ Rick Osterloh, Senior Vice President of Platforms & Devices at Google, discusses ongoing AI collaboration with Samsung.

Galaxy Z Fold7: A Larger Canvas for Galaxy AI

▲ Annika Bizon, Vice President of Product & Marketing at Samsung Electronics, highlights the Galaxy Z Fold7.

Pushing the limits of design, the Galaxy Z Fold7 is the slimmest Z Fold to date.

Features like Writing Assist and Drawing Assist help shape thoughts into polished prose and ideas into visuals. Now Brief displays insights — such as travel advisories, weather updates and exchange rates — by analyzing location, time and schedule.

▲ Circle to Search is demonstrated in a video.

Circle to Search has evolved to recognize in-game elements and provide contextual assistance without breaking immersion. Meanwhile, Vulkan optimizations boost graphics and responsiveness, powered by Snapdragon 8 Elite for Galaxy — engineered for next-level performance.

▲ The Galaxy Z Fold7 delivers next-generation resolution and effortless cropping.

For the first time, a 200-megapixel wide-angle camera headlines the Z Fold series, empowering users to shoot wide and crop tight without compromise. AI-powered editing tools have been optimized for the large display. Generative Edit now includes a new Suggest Erases feature that automatically detects and removes passersby. Audio Eraser offers intelligent sound isolation — with support for adjusting up to four sound types at once.

▲ Audio Eraser is demonstrated in a video.

Galaxy Z Flip7: A Full Experience, Even When Closed

▲ Dale Hogen, Mobile Communications at Samsung Electronics, reveals the Galaxy Z Flip7.

Compact yet uncompromising, the Galaxy Z Flip7 is the slimmest Z Flip yet. With a reengineered Flex Hinge and the largest battery in Galaxy Z Flip history, the device features a 6.9-inch bar-type display that delivers vivid visuals through an embedded polarizer.

The redesigned 4.1-inch FlexWindow spans edge to edge and supports a 120Hz refresh rate for ultra-smooth interaction. To maximize screen space, the bezel has slimmed to just 1.25 millimeters — nearly a third the thickness of its predecessor. Supporting numerous apps and widgets, One UI 8 brings greater functionality to the cover screen.

▲ The Galaxy Z Flip7 features a newly expanded Flex Window and thinner bezels.

The Galaxy Z Flip7 is a pocket-perfect AI assistant. Timely information — such as the day’s schedule or current playlist — appears on Now Bar. Meanwhile, holding the side button activates Google’s Gemini for hands-free AI. Gemini Live can even analyze outfits via the camera and suggest style tips based on the weather or calendar events.

▲ The Galaxy Z Flip7’s camera has FlexCam that allows users to take selfies in an easier way.

The 50-megapixel camera delivers sharp detail and true-to-life color thanks to the ProVisual Engine, and FlexCam gives users a one-of-a-kind selfie experience.

The revolutionary Galaxy Z Flip design is now even more accessible with the Galaxy Z Flip7 FE — featuring the same iconic foldable form, complete with a 50-megapixel camera, ProVisual Engine and Galaxy AI.

Galaxy Watch8: A New Standard for Personalized Health

▲ John Englehardt, Sales at Samsung Electronics, presents the Galaxy Watch8 series.

The Galaxy Watch8 series is an evolution in Samsung’s design philosophy to create a clearer, more iconic design identity with distinctive cushion design — first introduced on the Galaxy Watch Ultra. The slim design, combined with Dynamic Lug System provides an unparalleled all-day comfort. Galaxy Watch’s sleek form is complemented by its exceptional performance, with a new 3-nanometer processor, dual-frequency GPS and the advanced BioActive Sensor.

▲ Running Coach delivers personalized training.

The new Running Coach feature analyzes users’ running level and provides personalized insights to keep users motivated through the tailored coaching program. Simultaneously, Samsung Health informs users when it’s time to wind down via the new Bedtime Guidance feature.

▲ Vascular Load and other advanced health tracking features have been added.

Vascular Load monitors stress levels on the vascular system during sleep. Meanwhile, the Antioxidant Index uses the BioActive Sensor to measure carotenoid levels, delivering lifestyle insights for healthy aging.

The experience of having a true AI companion now comes full circle with the introduction of One UI 8 Watch across the Galaxy Watch8 series. In addition, the Galaxy Watch8 is the first smartwatch to come out of the box with Google’s Gemini and be powered by Wear OS 6.

Sustainability: A Commitment to the Planet

▲ This year’s Galaxy foldable alignwith Samsung’s sustainability vision.

Sustainability remains central to Galaxy’s design philosophy. The Galaxy Z Fold7 and Galaxy Z Flip7 incorporate nine recycled materials — including recycled lithium and plastics sourced from discarded fishing nets. These efforts align with Samsung’s broader Galaxy for the Planet initiative and reflect an enduring commitment to environmental stewardship.

The Experience Zone: A Galaxy of Possibilities, Unfolded

Attendees from around the world gathered in the product experience zone after the announcement, excited to explore the newly launched Galaxy devices. The Galaxy Z Fold7, in particular, drew attention for its noticeably slimmer, lighter build — with many eager to try it firsthand.

▲ The product experience zone draws a crowd at Galaxy Unpacked 2025.

“When I first saw the Galaxy Z Fold7, I was surprised by how slim and lightweight it is,” said Francisco Javier, a Samsung Member from Spain. “The larger screen makes a big difference.”

▲ Francisco Javier, a Samsung Member from Spain

“I love the Galaxy Z Flip7 because there are so many creative ways to use it,” said Ana Carolina Sandoval Diaz, an influencer from El Salvador. “I’m always making new content, and this gives me more freedom to do that.”

▲ Ana Carolina Sandoval Diaz, an influencer from El Salvador

“Samsung always surprises us — and this year, it’s how thin the Galaxy Z Fold7 is,” said Adi Fida, a journalist from Indonesia. “Despite the larger screen, it still feels easy to use with one hand.”

▲ Adi Fida, a journalist from Indonesia

“I like that the Galaxy Watch8 focuses on health,” said Bilge Suisik, an influencer from Türkiye. “I’ve never been great at sleeping, so I think it’ll help me get back on schedule — I could really use the reminders.”

▲ Bilge Suisik, an influencer from Türkiye

With the Galaxy Z Fold7, Galaxy Z Flip7, Galaxy Z Flip FE and Galaxy Watch8 series, Samsung has made a groundbreaking leap in delivering personalized, intelligent experiences that adapt, anticipate and empower. Galaxy AI is now more deeply embedded than ever across the Galaxy ecosystem — positioning Samsung at the forefront of a future where mobile technology is both personal and powerful.

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July 10, 2025
Levi Strauss lifts annual forecasts on steady denim demand in Europe despite tariff pain

July 10 (Reuters) – Levi Strauss LEVI.N raised its annual revenue and profit forecasts after beating quarterly estimates on Thursday, betting on strong demand for its denims in regions such as Europe in the face of tariff uncertainty.

The denim maker’s efforts to introduce new styles and collections including dresses, skirts and wide-legged jeans have helped it navigate a challenging market and subdued consumer spending, which continues to weigh on the retail industry.

In Europe, its net revenue rose 14% on a reported basis for the quarter ended June 1, compared with a 2% decline a year earlier.

Revenue in its direct-to-consumer segment increased 11% on a reported basis after rising 8% a year ago.

The Trump administration’s unpredictable trade policies with countries such as China and Vietnam have disrupted supply chains for apparel and footwear makers. However, Levi has been leveraging its diverse sourcing network to mitigate the impact from tariffs.

The company expects fiscal 2025 revenue to grow in the range of 1% to 2%, compared with a prior forecast of a 1% to 2% decline.

It also expects annual adjusted earnings per share to be between $1.25 and $1.30, compared with a previous forecast of $1.20 to $1.25 per share.

“Given our strong H1 and continued momentum across the business — and despite higher tariffs — we are raising our full-year revenue and EPS expectations,” Chief Financial Officer Harmit Singh said.

Levi said its forecast factors in 30% U.S. tariffs on Chinese imports and 10% on those from other countries, but assumes no significant worsening of the macroeconomic environment such as consumer strain, supply-chain disruptions or further tariff increases.

However, it expects a full-year gross margin expansion of 80 basis points, compared with 100 basis points projected earlier, due to a 20-basis-point impact from tariffs after mitigation plans.

The company’s quarterly revenue of $1.45 billion beat analysts’ estimate of $1.37 billion, according to data compiled by LSEG.

Its quarterly adjusted profit of 22 cents per share topped estimates of 13 cents per share.

(Reuters reporting by Anuja Bharat Mistry in Bengaluru; Editing by Pooja Desai)

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July 10, 2025
Newly-Discovered Meteorite Offers Insights into Volcanic Processes on Ancient Mars

The Martian meteorite Northwest Africa (NWA) 16254 is a 406-g gabbroic shergottite found two years ago in Algeria.

Image of the entire NWA 16254 sample studied by Chen et al.: (a) a backscattered electron (BSE) image obtained by the TESCAN Integrated Mineral Analyzer (TIMA); (b) mineralogical mapping via TIMA; (c) distribution map of the iron content obtained via TIMA; (d) distribution map of the calcium content obtained via TIMA. Image credit: Chen et al., doi: 10.15302/planet.2025.25002.

“Martian meteorites represent the only direct samples available in laboratory for studying the composition and evolution of the Martian mantle, as most are igneous in origin and retain geochemical fingerprints of mantle processes,” said lead author Dr. Jun-Feng Chen and colleagues at the Chengdu University of Technology.

“Among these available samples, shergottites, comprising approximately 90% of the Martian meteorite collection, are particularly critical for deciphering mantle dynamics, crust-mantle interactions, and magmatic differentiation on Mars.”

“Shergottites are classified into four petrological subtypes depending on their distinct textural and mineralogical characteristics: including basaltic, olivine-phyric, poikilitic, and gabbroic.”

“These variations reflect distinct formation environments, ranging from shallow subsurface crystallization to potential surface eruptions, with gabbroic shergottites notably preserving coarse-grained textures indicative of slow cooling in crustal magma chambers.”

In the new study, the authors combined advanced mineralogical mapping and geochemical analyses to decode the history of NWA 16254.

They revealed decoupled geochemical behaviors in pyroxene cores and rims, a phenomenon critical for reconstructing magma chamber dynamics.

“Our study reveals that NWA 16254 formed initially under high-pressure conditions (4.3-9.3 kbar) at the Martian mantle-crust boundary, where magnesium-rich pyroxene cores crystallized,” the researchers said.

“Later, the magma ascended to shallow crustal depths (<4 kbar), where iron-enriched pyroxene rims and plagioclase developed.”

“This prolonged cooling process, preserved in the meteorite’s coarse-grained texture, suggests episodic melt extraction from a long-lived, depleted mantle reservoir — a critical clue for reconstructing Mars’ magmatic evolution.”

“The meteorite’s geochemical depletion, marked by light rare earth element depleted and low oxygen fugacity, aligns it with a meteorite called QUE 94201, hinting at a shared magma source.”

“Its gabbroic texture, indicative of slow cooling in crustal chambers, distinguishes it as a unique archive of subsurface magmatism.”

“These findings challenge existing models of Martian volcanic evolution, as NWA 16254’s consistently low oxygen fugacity, corroborated by Ti³⁺-bearing ilmenite assemblages, implies sustained reducing conditions during crystallization.”

“This underscores the heterogeneity of Mars’ mantle and raises questions about the planet’s redox evolution over billions of years.”

“Future geochronological studies could resolve whether this meteorite represents ancient mantle melting (2.4 billion years ago) or younger magmatic activity, offering clues to Mars’ thermal history.”

The team’s paper was published May 13, 2025 in the journal Planet.

_____

Jun-Feng Chen et al. Petrography and geochemistry of a newly discovered Martian gabbroic shergottite NWA 16254. Planet, published online May 13, 2025; doi: 10.15302/planet.2025.25002

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July 10, 2025

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