In this recap of 7 FDA updates and 2 interview spotlights in allergy from the first half of 2025, we review important advances in allergy care. At the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) in San Diego, oral immunotherapy showed promise for peanut allergy in young children, and tezepelumab improved nasal polyp severity in CRSwNP.
US Food and Drug Administration (FDA) activity included the acceptance of Anaphylm’s epinephrine film NDA, the approval of garadacimab-gxii for HAE, and new warnings for cetirizine. Additional approvals expanded access to omalizumab biosimilars, pediatric HAE treatment, and a needle-free option for pediatric anaphylaxis.
In the phase 3 WAYPOINT trial, tezepelumab significantly reduced nasal polyp severity and nasal congestion in patients with CRSwNP. The treatment lowered the need for surgery by 92% and improved symptoms like loss of smell and quality of life scores, showing early and sustained benefit over 52 weeks.
At AAAAI 2025, Scott Sicherer, MD, from Mt. Sinai School of Medicine, presented phase 2 data showing that 100% of children with high-threshold peanut allergy on oral immunotherapy tolerated 9043 mg of peanut, versus 10% in the avoidance group. The study highlights a promising, simple treatment option—using store-bought peanut butter under allergist supervision.
Approval date: June 16, 2025.
The FDA approved garadacimab-gxii (ANDEMBRY), the first treatment targeting factor XIIa to prevent hereditary angioedema (HAE) attacks in patients aged ≥ 12 years. In the VANGUARD trial, it reduced HAE attacks by over 99%. The once-monthly, citrate-free injection offers a convenient, effective option for long-term HAE management with a strong safety profile.
Approval date: March 9, 2025
The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, food allergy, and chronic spontaneous urticaria. Phase 3 data confirmed its bioequivalence, safety, and efficacy, offering a more affordable treatment option to expand patient access and reduce healthcare costs.
Approval date: March 5, 2025
The FDA approved 1 mg neffy epinephrine nasal spray for children aged 4+ weighing 15–30 kg, offering a needle-free alternative for pediatric anaphylaxis. This user-friendly design may reduce hesitation, improve adherence, and enhance emergency treatment outcomes. Availability is expected by May 2025.
PDFA date: January 31, 2026
The FDA accepted the NDA for Anaphylm, a needle-free epinephrine sublingual film for severe allergic reactions, with a target decision date of January 31, 2026. Clinical data showed rapid symptom relief and no serious adverse events. If approved, Anaphylm could transform anaphylaxis care with its portable, easy-to-use design.
PDUFA date: September 12, 2025
The FDA accepted BioCryst’s NDA for berotralstat oral granules to prevent HAE attacks in children aged 2–11 years, granting priority review with a target decision date of September 12, 2025. If approved, it would be the first oral prophylactic therapy for HAE in children under 12 years.
Palforzia is now available in the US for children aged 1–3 years with confirmed peanut allergy, addressing a critical unmet need. FDA approval, based on the successful POSEIDON trial, supports early oral immunotherapy to desensitize young children and help prevent peanut allergy progression during immune development.
The FDA is adding warnings to cetirizine and levocetirizine labels after identifying rare cases of severe itching (pruritus) upon stopping long-term use. Most of the 209 global cases occurred in the US. Patients should be informed of this risk before starting treatment, especially for chronic use.
The Morning Show, with its dramatic exploration of current events through the lens of a popular broadcast news program on the fictitious network UBA, shows no signs of slowing its pace, says star Jennifer Aniston, who teased an “emotional” forthcoming fourth season of the Apple TV+ series.
“The Morning Show is just a beast to film,” she told People recently. “It is layered, it’s complicated, it’s emotional, it hits on a lot of topics and current events, so let’s just say, it’s not Friends.”
Aniston, who also executive produces the series alongside fellow co-star Reese Witherspoon, said wearing dual hats on The Morning Show “takes a lot out of you.” She continued, “We’re involved in every single aspect of the show, on top of just the performance side, which is a big piece of it. But I’ve got incredible support, and we have such an incredible team.”
After filming on Season 4 wrapped in December 2024, Aniston told the outlet earlier this year that production on the latest installment “was so hard,” teasing, “But it’s a great season. It’s jam-packed, that’s for sure.”
While plot details are still sparse, new cast members are soon to enter the fray, including Marion Cotillard and Aaron Pierre, who will join an ensemble cast also featuring Billy Crudup, Mark Duplass, Néstor Carbonell, Karen Pittman and Greta Lee.
Season 3 followed the gargantuan merger between UBA and rival network YDA, as well as the introduction of Jon Hamm’s duplicitous space/tech billionaire Paul Marks, who struck up a romance with Aniston’s Alex. Meanwhile, Witherspoon’s Bradley’s status as a journalist hangs in the balance after she chose not to reveal the video evidence of her brother having participated in the insurrection at the U.S. Capitol.
Previously, showrunner Charlotte Stoudt told Deadline at the Contender’s TV event that next season would explore deepfakes and artificial intelligence.
“We blew everything up last year with the biggest bomb we could possibly build,” she said at the time. “So, we have to ask ourselves how is the band going to get back together, and what will that look like? We get into the world of deepfakes and AI and the misinformation in the fog of war that we’re seeing now in the Middle East and stuff. We’re looking at who can trust. And can you trust what you’re seeing? Can you trust yourself? Can you trust your news outlet?”
The Morning Show returns to Apple TV+ Sept. 17.
Frontline Tislelizumab Plus Chemo in
Locally Advanced ESCC | Image Credit: ©
Ashling Wahner & MJH Life Sciences Using AI
The frontline combination of tislelizumab-jsgr (Tevimbra) plus chemotherapy demonstrated efficacy improvements over chemotherapy alone in patients with locally advanced esophageal squamous cell carcinoma (ESCC), with similar improvements noted in those with locally advanced disease and a tumor PD-L1 tumor area positivity (TAP) score of at least 5%, according to findings from a subgroup analysis of the phase 3 RATIONALE-306 study (NCT03783442).1
The data, which were shared during the 2025 ESMO Gastrointestinal Cancers Congress, the median overall survival (OS) with tislelizumab plus chemotherapy (n = 49) was 25.6 months (95% CI, 19.4-36.3) in the subgroup of patients with locally advanced disease vs 12.3 months (95% CI, 9.0-21.7) with chemotherapy (n = 39), translating to a 51% reduction in the risk of death (HR, 0.49; 95% CI, 0.29-0.84; P = .0037). The 12- and 24-month OS rates in the tislelizumab arm were 78.5% and 53.5%; in the placebo arm, these rates were 50.9% and 22.6%. The median investigator-assessed progression-free survival (PFS) with tislelizumab was 9.7 months (95% CI, 6.9-19.6) vs 6.9 months (95% CI, 4.2-9.7) with placebo (HR, 0.56; 95% CI, 0.31-1.01; P = .0262); the respective 12-month PFS rates were 46.2% and 18.2%.
Those with locally advanced ESCC and a PD-L1 TAP score of 5% or higher who received tislelizumab plus chemotherapy (n = 25) experienced a median OS of 26.4 months (95% CI, 15.3-not evaluable [NE]) vs 11.5 months (95% CI, 8.6-19.8) with chemotherapy alone (n = 20), translating to a 63% reduction in the risk of death (HR, 0.37; 95% CI, 0.16-0.83; P = .0067). The 12-month OS rates in the tislelizumab and placebo arms were 72.0% and 45.2%, respectively; the rates at 24 months were 56.0% and 16.9%, respectively. The median investigator-assessed PFS in the tislelizumab arm was 13.2 months (95% CI, 6.8-30.2) vs 6.7 months (95% CI, 4.2-8.6) in the placebo arm (HR, 0.44; 95% CI, 0.19-1.02; P = .269; the respective 12-month PFS rates were 52.4% and 14.8%.
“In this subgroup analysis of patients with locally advanced ESCC, first-line tislelizumab plus chemotherapy showed substantial and clinically meaningful improvements in efficacy, consistent with the primary and 3-year long-term follow-up analyses,” Eric Van Cutsem, MD, PhD, of the Division of Digestive Oncology at University Hospitals Gasthuisberg, Leuven, and KU Leuven, in Leuven, Belgium, said in a presentation of the data. “These findings further support the use of tislelizumab plus chemotherapy as a first-line treatment option for patients with locally advanced ESCC.”
The double-blind, randomized, global, phase 3 study enrolled patients with unresectable locally advanced or metastatic ESCC who had measurable or evaluable disease by RECIST v1.1 criteria and an ECOG performance status no higher than 1. Patients had not previously received systemic therapy for advanced disease. They were randomized 1:1 to receive placebo or 200 mg of tislelizumab every 3 weeks plus chemotherapy in the form of platinum plus fluoropyrimidine or platinum plus paclitaxel. Maintenance treatment continued until intolerable toxicity or progressive disease. They were stratified by geographic region (Asia excluding Japan vs Japan vs rest of the world), previous definitive therapy (yes vs no), and investigator-selected chemotherapy regimen (platinum plus fluoropyrimidine vs platinum plus paclitaxel).
The primary end point of the study was OS in the intention-to-treat (ITT) population and secondary end points were OS in the subgroup of patients with a PD-L1 TAP score of 10% or higher, PFS, objective response rate (ORR), duration of response (DOR), health-related quality of life, and safety.
Prior data from the study showed that after a minimum follow-up of 3 years, the median OS in all patients who received tislelizumab plus chemotherapy (n = 326) was 17.2 months (95% CI, 15.8-20.1) vs 10.6 months (95% CI, 9.3-12.0) with placebo plus chemotherapy (n = 323), translating to a 30% reduction in the risk of death (HR, 0.70; 95% CI, 0.59-0.83; P < .0001).2 In the tislelizumab arm, the 12-, 24-, and 36-month OS rates were 65.0%, 37.9%, and 22.1%, respectively; in the placebo arm, the respective rates were 44.7%, 24.8%, and 14.1%. In March 2025, the FDA approved tislelizumab plus platinum-containing chemotherapy for first-line use in adult patients with unresectable or metastatic ESCC with a tumor PD-L1 expression of 1 or higher based on RATIONALE-306 data.3
The subgroup analysis sought to evaluate OS and PFS in patients with locally advanced ESCC, which accounted for 13.6% of the 649 patients, including those with both locally advanced ESCC and a tumor PD-L1 TAP score of 5% or higher, which accounted for 51.1% of 88 patients.1 Those with nonmetastatic disease who were not fit for surgery or definitive chemoradiation were retrospectively selected and included in the analysis.
The baseline demographic and disease characteristics in the locally advanced ESCC subgroup were consistent with those of the ITT population, Van Cutsem said.
Additional efficacy data showed that in the locally advanced ESCC subgroup, the investigator-assessed ORR with tislelizumab plus chemotherapy was 61.2%, which comprised a complete response (CR) rate of 12.2% and a partial response (PR) rate of 49.0%. With chemotherapy alone, the investigator-assessed ORR was 38.5%, with a CR rate of 12.8% and a PR rate of 25.6%. The time to response (TTR) with tislelizumab was 1.4 months (range, 1.2-23.3) vs 2.6 months (range, 1.2-4.2) with placebo. The median DOR was 12.6 months (95% CI, 6.9-22.1) and 7.1 months (95% CI, 5.5-16.6) in the respective arms.
In the locally advanced ESCC subgroup that also had a PD-L1 TAP score of 5% or higher, the respective ORRs were 68.0% and 30.0%. In the tislelizumab arm, the CR and PR rates were 16.0% and 52.0%, respectively; in the placebo arm, these respective rates were 10.0% and 20.0%. The median TTR was 1.5 months (range, 1.2-23.3) with tislelizumab vs 2.0 months (range, 1.2-2.7) with placebo. The median DOR in the respective arms was 22.1 months (95% CI, 6.1-NE) and 5.7 months (95% CI, 1.5-NE).
The toxicity profile of tislelizumab combined with chemotherapy in the locally advanced subgroup was consistent with that reported in the ITT population, according to Van Cutsem, who added that no new safety signals were observed.
In the locally advanced ESCC subgroup, 100% and 97.4% of those in the tislelizumab and placebo arms experienced at least 1 treatment-emergent adverse effect (TEAE); 65.3% and 74.4% of the cases were grade 3 or higher, 44.9% and 51.3% were serious, and 6.1% and 5.1% proved fatal. Moreover, 100% of those in the tislelizumab arm and 92.3% of those in the placebo experienced at least 1 treatment-related adverse effect; 59.2% and 59.0% were grade 3 or higher, 28.6% and 20.5% were serious, and 28.6% and 20.5% led to death. TEAEs resulted in treatment discontinuation for 40.8% of those in the tislelizumab arm vs 35.9% of those in the placebo arm. In the tislelizumab arm, 42.9% of patients received subsequent anticancer therapy and 18.4% received subsequent radiation; in the placebo arm, these respective rates were 51.3% and 30.8%.
Disclosures: Van Cutsem disclosed having participated in advisory boards for AbbVie, Agenus, ALX, Amgen, Arcus Biosciences, Astellas, AstraZeneca, Bayer, BeOne Medicines, Bexon Clinical, BioNtech, Boehringer Ingelheim, Bristol Myers Squibb, Canfour, Daiichi Sankyo, Debiopharm, Elmedix, Eisai, Galapagos, GSK, Hookipa Pharma, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Simcere, Takeda, Taiho Pharmaceutical, and Terumo.
With six stages over a competitive distance of 98.34 kilometres remaining, Charpentier is 3.2sec ahead of Abramowski, who is also competing in a Ford Fiesta Rally3 on Pirelli tyres.
However, it could have been a three-way battle for first place had Gill not hit trouble nearing the finish of the morning loop.
Taylor Gill’s Rome debut did not go as planned
© At World
Making his FIA European Rally Championship debut, Australian Gill, part of the FIA Rally Star talent detection initiative, was leading by 20.4sec after he won stages two and three of his first Tarmac start since the Croatia Rally in April 2024. But it all went wrong after the penultimate stage of the morning.
The FIA Junior WRC Championship leader explained: “Basically the fuel pump just died after the 34-kilometre stage. We were exiting the stage and after a few kilometres the car just stopped and couldn’t restart. There’s no damage or anything, the car is already fixed and we’ll restart tomorrow and try set some good stage times.”
Gill’s exit left Abramowski leading Charpentier by 0.2sec at the midday service halt in Fiuggi after the Frenchman went off and briefly got stuck in a ditch on SS4.
Tymek Abramowski is set to pounce on Sunday at Rally di Roma Capitale
© At World
While Abramowski, the ERC3 points leader who turns 19 on Monday, focused on an error-free afternoon, Charpentier moved into first place on SS5 and remained in front despite a moment on SS6.
“We touched a haybale [SS6] but otherwise it was really tough and really hot,” ex-circuit racer Charpentier said. “We have a lack of pace so we’ll have to figure that out this evening and push tomorrow. We clipped the haybale with the rear right and now the wheel is a bit bent so we had to finish like this.”
Abramowski, competing on Tarmac for only the second time, said: “I tried to keep the pace and don’t do mistakes like on the first loop when I was too slow or too fast in some cuts.”
Hubert Kowalczyk is a strong third despite set-up issues masking the Renault Clio Rally3 driver’s ultimate pace in the afternoon. “Doing the rally last year helps me because I know a little bit this Tarmac, this grip, but I have so much work and I don’t have time to prepare enough,” the 21-year-old from Poland explained. “Watching my first onboard was in the aeroplane coming here so I try to make what I can.”
Hubert Kowalczyk in action on Saturday at Rally di Roma Capitale
© At World
Casey-Jay Coleman is on course for an ERC3 career-best fourth after a solid showing from the Irishman. “There was a lot more gravel on the roads than expected but I managed the longer stage in the afternoon better than the first run by conserving the tyres and the brakes,” he said.
Adam Grahn is fifth on his Tarmac debut with Błażej Gazda and Sebastian Butyński sixth and seventh respectively. Martin Ravenščak, with sister Dora co-driving, overcame brake issues to complete leg one in eighth place.
After winning SS1 on the streets of Rome last night, Adrian Rzeźnik was hit by an electronics failure on SS2. Although he and co-driver Kamil Kozdroń, who is making his 130th start, tried to fix the issue, they were forced to retire on SS3.
Hubert Laskowski stopped with suspension damage after SS4 but is set to restart on Sunday.
Sunday’s action begins at 08:25 local time with the first run through the 11.58-kilometre Guarcino – Altipiani stage.
Posted in: Games, Mobile Games, Netmarble | Tagged: Tower Of God: New World
Tower of God: New World has a new update available as players can get in on some events leading up to its Second Anniversary
Netmarble dropped a new update for Tower of God: New World this week, in which they celebrate 2nd Anniversary Eve. Yes, in true mobile game fashion, we can’t just wait to celebrate a proper anniversary event, we have to throw an event for the event to come, and we’re sure there will be an event celebrating how we celebrated the event after that one. We have more details below as you’ll get two new characters added to the mix and the usual pairing of events, as this will run for the next few weeks.
Two new Teammates have been introduced as part of the update. SSR+ [Fairy Sword] Sharon (Yellow Element, Warrior, Fisherman) is a High Ranker from the Ari Family and the 1st Division Commander of Zahard’s 4th Army, known for her exceptional Needle combat skills and mastery of Shinsu control. Sharon excels at both protecting her allies and maximizing damage output. XSR+ [Regular] Khun Mascheny (Purple Element, Ranged, Spear Bearer), an IF (imaginary) version of Khun Mascheny, is based on the character during her time climbing the Tower as a Regular. Tower of God: New World celebrates its 2nd Anniversary Eve with limited-time events, offering players the chance to earn generous rewards:
Additional events and content, including Tower Fun Run, Lucky Wheel, Event Boss Battle, and Memorial Pocket are available through August 13 that provide players the opportunity to obtain various in-game rewards.
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