McLaren driver Lando Norris set the pace during Friday’s second practice session for the Hungarian Grand Prix, leading the way from team mate Oscar Piastri and Ferrari’s Charles Leclerc, while Max Verstappen is set to take a trip to the stewards after a strange on-track moment.
Held in partly cloudy but warm conditions, FP2 offered drivers another chance to get a feel for the revamped Hungaroring circuit and fine-tune their set-ups, with cars quick to head out when the green light switched on at the end of the pit lane at 1700 local time.
That flurry included Aston Martin’s Fernando Alonso, who sat out FP1 to nurse a muscular injury in his back, and Gabriel Bortoleto, who had given his Kick Sauber car to Paul Aron for the former F2 racer’s second Friday on loan from Alpine.
It did not take long for the first talking point to emerge, with Nico Hulkenberg running wide at Turn 12 and flicking some gravel onto the track – Haas driver Esteban Ocon and Alpine’s Franco Colapinto both asking their teams to check for potential damage after running through it.
There was also an early moment for Piastri at Turn 4, where the McLaren challenger stepped out during the high-speed entry, while George Russell and Ollie Bearman got close to each other through Turn 9 as their early running converged.
Once all 20 drivers had got laps on the board, Norris held the provisional P1 spot with a time of 1m 16.525s on medium tyres, 0.172s clear of championship-leading team mate Piastri, and almost half a second faster than Leclerc’s Ferrari.
Further back, Red Bull were enduring a difficult start to the session, with Yuki Tsunoda reporting over the radio that “the balance is so messy” and Verstappen lamenting problems at the “front and rear” – adding that “it’s like driving on ice”.
As the halfway mark approached, teams gradually swapped their medium and hard rubber for softs to get some Qualifying simulations in, bringing another wave of purple and green sector times and giving a hint at what’s to come on Saturday afternoon.
McLaren maintained their superiority across this phase, thanks to Norris producing a 1m 15.624s and Piastri clocking a 1m 15.915s – despite the former backing out of his first lap with a wide moment at Turn 2 and later going off at the final corner, and Piastri hitting a bunch of traffic.
Aston Martin drivers Lance Stroll and Alonso pulled out impressive-looking laps to end the session in fourth and fifth respectively, just behind Leclerc, while the other Ferrari of Lewis Hamilton rounded out the top-six places.
Russell was the fastest Mercedes driver in seventh, followed by Racing Bulls rookie Isack Hadjar and Tsunoda, with team mate Kimi Antonelli completing the top-10 over Haas pair Bearman and Ocon and Hulkenberg’s Sauber.
Verstappen finished the session all the way back in 14th position amid further balance complaints – the stewards also summoning him after a peculiar incident at Turn 3, where the Dutchman slowed his Red Bull to a crawling pace and appeared to throw a towel out of the cockpit.
Next up was Liam Lawson in the second Racing Bulls machine, taking 15th over Williams duo Carlos Sainz and Alex Albon and Sauber man Bortoleto, with Alpine drivers Pierre Gasly and Colapinto bringing up the rear of a field covered by 1.5 seconds.
Drivers and teams will now regroup in the Hungaroring paddock to dig through the data and prepare for Saturday’s running – FP3 due to begin at 1230 local time and the all-important Qualifying session following at 1600.
By SUSAN RECKLING, MA Posted: 8/1/2025 12:10:00 PM
Last Updated: 8/1/2025 11:20:40 AM
New research out of Spain has shown that patients with cancer who had lower levels of the biomarker CD69 (receptor on T cells) before starting treatment with immune checkpoint inhibitors (ICIs) had a more negative immune response and were at higher risk of cardiovascular damage and myocarditis.1 Although more work is needed to validate this potentially cardioprotective biomarker, these study findings may indicate the need to monitor this population more closely and may help researchers develop new treatments to prevent the immune dysregulation seen in these patients.
“Immune checkpoint inhibitors have revolutionized cancer treatment, but they can also damage the hearts of some patients,” stated Pilar Martín, PhD, who presented these findings at the 2025 European Society of Cardiology (ESC) Cardio-Oncology Annual Conference in Florence, Italy. “In this study, we monitored how levels of immune cells, which are known to be involved in the development of heart diseases, change after treatment.” Dr. Martín is Assistant Professor and Head of the Regulatory Molecules of Inflammation Lab at the Spanish National Center for Cardiovascular Research (CNIC), Madrid, and group leader at CIBER-CV (Center for Biomedical Network Research Cardiovascular).
“We were surprised to see an early and rapid loss of protective immune cells (regulatory T cells) after cancer patients started treatment,” she added. “This suggests a window of vulnerability early in treatment.”
Background
Among the cardiovascular toxicities associated with immune checkpoint inhibitors are cardiomyopathy, pericarditis, arrhythmia, conduction abnormalities, and myocarditis. And, according to Dr. Martín, it is “just the tip of the iceberg,” with more novel therapies emerging.
In an observational cohort study of more than 2,600 adults who received at least one dose of an immune checkpoint inhibitor, 27 (1%) were diagnosed with immune checkpoint inhibitor–induced myocarditis.2 The investigators noted that at diagnosis, these individuals had elevated levels of high-sensitivity troponin T, alanine aminotransferase, aspartate aminotransferase, and creatine phosphokinase (CPK). “An increase in noncardiac biomarkers during ICI treatment, notably CPK, should prompt further evaluation for ICI myocarditis,” they concluded.
“Myocarditis is one of the most lethal secondary effects of immune checkpoint inhibitors,” noted Dr. Martín. In fact, a retrospective cohort study of 160 patients with suspected immune checkpoint inhibitor–induced myocarditis at Massachusetts General Brigham Health System revealed that severe ICI-induced myocarditis (n = 28) was linked to increased 1-year cardiovascular mortality.3 However, 1-year cardiovascular hospitalization rate and long-term left ventricular ejection fraction were similar across all groups (severe, nonsevere, negative).
Dr. Martín also mentioned the importance of tracking the dynamics of cardiac troponins in patients with different tumors treated with immune checkpoint inhibitors.4 Among the cardiovascular assessments for such patients are history, presentation, physical exam; ECG and biomarkers; echocardiography with global longitudinal strain; cardiac MRI with parametric mapping; and pathology.
Study Details
In the prospective cohort substudy, the investigators analyzed blood samples from 215 patients with cancer from the Spanish Immunotherapy Registry of Cardiovascular Toxicity (SIR-CVT) before treatment and at four other intervals: at 2 to 4 weeks; 10 to 12 weeks; 6 months; and 1 year after treatment with immune checkpoint inhibitors. A total of 19 centers participated in this study, with an estimated sample size of 500 patients within 12 months. And at the 2025 ESC-Cardio-Oncology meeting, Dr. Martín presented the results from the first 215 patients.
“Those with lower expression of CD69 had a twofold higher risk of cardiovascular disease than did those with higher expression of CD69.”
— PILAR MARTÍN, PhD
Tweet this quote
The goals of the study are to register risk factors and daily practice management of cardiovascular toxicity in patients with solid organ cancer receiving immune checkpoint inhibitors; define clinical, ECG, imaging, laboratory, and genetic markers for early diagnosis of cardiotoxicity; study the immunologic profile of patients on immune checkpoint inhibitors and the potential of human microRNA (miR-721) as a biomarker for early diagnosis of immune checkpoint inhibitor–induced myocarditis5; and evaluate the impact of cardiac monitoring on the reduction of inappropriate treatment suspensions.
Patients had a range of different cancers, including non–small cell lung cancer (57%), breast cancer (7%), and melanoma (7%), and were treated with different types of immune checkpoint inhibitors (PD-1, PD-L1, and CTLA-4). Median patient age was 68; 68% were male, 83% had at least one cardiovascular risk factor, and 32% has previous cardiac disease. The phenotyping before the initiation of immunotherapy included biomarkers such as cardiovascular magnetic resonance, ecologic (environmental stressor’s impact), troponin plus B-type natriuretic peptide, ECG, and miR-721.
The focus was on T regulatory cells (CD4+FOXP3+CD69+) and proinflammatory Th17 cells (CD4+IL-17+). Based on CD69 expression, patients were stratified into high- and low-risk groups for cardiovascular diseases. “We know that the ligands that activate this molecule are very much related to cardiovascular disease,” said Dr. Martín. Changes in the levels of the patients’ immune cell populations were monitored over time.
Key Results
During the assessment of CD4-positive cells, they were separated into memory and naive cells. In brief, the memory CD4-positive T cells are long-lived antigen-specific T cells, whereas naive cells are mature T cells that have not yet encountered their specific antigen. In the CD4-gated populations, within the first week after immune checkpoint inhibitor therapy was initiated, “we see how the percentage of CD4-positive memory cells declines and the percentage of CD4-positive naive cells rise[s],” commented Dr. Martín. “And the same more or less can be seen with the T regulatory cells–gated populations.”
In addition, Dr. Martín noted, patients who had lower baseline CD69 expression experienced a pronounced decline, “suggesting increased susceptibility to cardiovascular toxicity.” Such a decline in these protective immune cells has previously been linked to a higher risk of developing cardiovascular complications such as myocarditis.6
Some patients with cancer may experience cardiovascular complications from treatment with immune checkpoint inhibitors, with myocarditis representing one of the most lethal secondary effects of these immunotherapies.
A recent study has identified CD69 expression as a potential protective biomarker against cardiac damage associated with immune checkpoint inhibitors.
Patients who had lower levels of CD69 expression before starting treatment with immune checkpoint inhibitors experienced a more negative immune response and so were at higher risk of heart damage.
Finally, an increase in cytotoxic CD8-positive T cells after 3 weeks was noted, and this change became significant at weeks 11 and 26 after immune checkpoint inhibitor therapy. “For me, the more interesting data are the drop in the T regulatory cells’ expression of CD69 during the 3 first weeks after immune checkpoint inhibitor treatment, indicating a loss of peripheral immune tolerance,” Dr. Martin said. “And most patients experienced a steady increase in Th17 cells after immune checkpoint inhibitor treatment after 1 year.”
Clinical Implications of Distinct Immune Profiles
Upon bioinformatic analysis, the study authors confirmed distinct immune profiles between those at high and low risk of immunotherapy-related cardiovascular disease. “We saw these groups had very different response to the cancer treatments,” stated Dr. Martín. “Those who had lower levels of CD69 before starting treatment had a more negative immune response, which puts them at much greater risk of heart damage.” In fact, those with lower expression of CD69 had a twofold higher risk of cardiovascular disease than did those with higher expression of CD69, she added.
The study authors believe these results may pave the way for personalized strategies to stratify patients by CD69 expression to potentially identify those at higher risk of developing cardiovascular toxicity when undergoing treatment with immune checkpoint inhibitors. “Analysis of the immunologic phenotype of patients before starting immunotherapy is very important,” Dr. Martín concluded.
DISCLOSURE: Dr. Martín reported no conflicts of interest.
REFERENCES
Martín P, Ortega-Sollero E, Ruiz-Fernandez I, et al: Immune profiling of cancer patients in the Spanish Immunotherapy Registry of Cardiovascular Toxicity (SIR-CVT). 2025 ESC Cardio-Oncology Annual Conference. Presented June 20, 2025.
Vasbinder A, Chen YA, Procureur A, et al: Biomarker trends, incidence, and outcomes of immune checkpoint inhibitor-induced myocarditis. JACC CardioOncol 4:689-700, 2022.
Ben Zadok OI, Levi A, Divakaran S, et al: Severe vs nonsevere immune checkpoint inhibitor-induced myocarditis: Contemporary 1-year outcomes. JACC CardioOncol 5:732-744, 2023.
Zatarain-Nicolás E, Martín P, Rodas IM, et al: Cardiovascular toxicity of checkpoint inhibitors: Review of associated toxicity and design of the Spanish Immunotherapy Registry of Cardiovascular Toxicity. Clin Transl Oncol 25:3073-3085, 2023.
Blanco-Domínguez R, Sánchez-Díaz R, de la Fuente H, et al: A novel circulating microRNA for the detection of acute myocarditis. N Engl J Med 384:2014-2027, 2021.
Cruz-Adalia A, Jiménez-Borreguero LJ, Ramírez-Huesca M, et al: CD69 limits the severity of cardiomyopathy after autoimmune myocarditis. Circulation 122:1396-1404, 2010.
‘Skyfall’ concept could deploy a helicopter swarm on Mars Astronomy Magazine
AV Reveals Skyfall: Future Concept Next-Gen Mars Helicopters for Exploration and Human Landing Preparation PR Newswire
Jaw-Dropping Video Shows NASA’s Plan to Deliver a Helicopter Swarm to Mars Without Landing Gizmodo
“NASA Calls It the ‘Skyfall Maneuver’” as Plan to Drop 6 Mars Helicopters Mid-Air Divides Experts and Fuels Outrage Over Billion-Dollar Space Risks Rude Baguette
Always a sporty soul, Amo-Dadzie had a base level of fitness from the numerous sports in played.
“I used to play football, 11-a-side, five-a-side,” the Londoner told us. “I was going to the gym, even prior to starting track and field. I did a little bit of boxing. I had one spar, got hit in the face, didn’t like it, so that was the end of that.
“Then I also did a taster session with London Blitz, an American football team in London, and couldn’t catch, so being a wide receiver wasn’t going to work out either.”
So he felt like he was in pretty good shape when he finally decided to become a fully paid-up member of Woodford Green Athletics Club in East London.
Not so.
“My body was in a good place, but I would say nothing quite prepares you for the physical rigours of being a sprinter.”
Various injuries and niggles impacted his first few years, with Amo-Dadzie describing the period as “a shock to my body system”.
But it wasn’t just the physical aspects he was learning about.
“My first ever race was a 60m race, and I didn’t know much about athletics other than at the time, I knew the world record for 60m was 6.34 seconds by Christian Coleman. So I remember my first race I ran, it was 60m and I ran 7.03 seconds. So it’s very close to the seven-second barrier and… people were saying to me, if you run under seven, that’s like a big deal, not many people do that. In the second round, I ran 6.97, so that was a really cool moment.”
Seeing the results beginning to come, despite also working full-time and being present for his wife and new daughter, Amo-Dadzie went on to break the magical 10-second barrier for the men’s 100m aged 30. By 31 he made his World Championships debut, and the following year, just missed out on being selected for the Olympic Games Paris 2024.
Yet dropping the ball on any of those important aspects of his life was not an option.
“My life is a very fine balance,” he said. “I’m a father as well, so for me my role as a husband can’t suffer, my role as a father can’t suffer, my role as an accountant can’t suffer. My role as a governor (at a primary school) can’t suffer. Me being a sprinter, none of these things can suffer, which means… I need to be careful about things that might tip it the wrong way.”
Aware that his partner didn’t sign up for this new aspect of his life when they met, Amo-Dadzie is full of praise.
“My wife is very good at spotting when I’ve had a long day today,” he acknowledged. “I’ve come back from work, I’m putting baby to sleep and I’m going to go training. She’s like, you know what, take it easy today, babe, and just her saying that lets me know that she’s seen that maybe I look a bit stretched thin this week. So my support network is unbelievable.”
German biathlete’s body left on Pakistani peak due to risk and respect, say fellow climbers
SKARDU, Pakistan: German Olympic champion Laura Dahlmeier’s climbing partners said on Thursday the decision to leave her body on a remote peak in Pakistan was based on dangerous conditions and her own written wishes that no one should risk their life in a recovery attempt.
Dahlmeier, a double gold medalist in biathlon, was struck by a falling rock on July 28 while descending Laila Peak in the Karakoram range. She lost consciousness immediately and showed no signs of life, according to her climbing partner
Marina Eva Krauss, who said she was unable to reach her without endangering herself amid an ongoing rockfall.
“It was clear to me that the only way to help her was to call the helicopter,” Krauss told Reuters in Skardu. “I called her and there was no response and she had just stopped moving … I saw that she had been hit on the head and that she only had a chance if help arrived immediately.”
Marina Eva (second right) mountaineering partner of German Olympic biathlon champion Laura Dahlmeier, looks on during a press conference along with the rescue team members in Skardu in Pakistan’s mountainous Gilgit-Baltistan region on July 31, 2025. (AFP)
Laila Peak, a dramatic 6,069-meter spire in Gilgit-Baltistan’s Hushe Valley, is known for its steep and technical routes. Dahlmeier was descending at roughly 5,700 meters when the rockfall occurred. Poor weather conditions prevented helicopter access, and two expert teams from Germany and the United States later confirmed her death on July 30.
Speaking alongside Krauss, German climber and rescue team member Thomas Huber said the rockfall had continued after Dahlmeier was struck.
“So, she was in a kind of safe spot and every attempt to go to Laura would cause her life [to be in danger],” he said.
Huber added that Dahlmeier, 31, was deeply aware of the risks of mountaineering and had made her wishes known in case of such an outcome.
“We discussed this matter to recover the body, of course, but we [knew] Laura — how her mentality [was] — and we [knew] exactly if the body recovery were a risk, she wouldn’t want this, because she [was] a mountain girl.”
Dahlmeier’s management had earlier confirmed her position, saying that she had left written instructions requesting that no one risk their life to retrieve her body, and that she wished to remain on the mountain in such a case — a sentiment her fellow climbers repeated.
“Now she is on a beautiful mountain, and we should respect this,” Huber said.
Winner Laura Dahlmeier of Germany competes during the Women’s 15 km individual race during the 2017 IBU Biathlon World Championships in Hochfilzen, on February 15, 2017. (AFP/File)
The rescue mission was officially called off on July 30, according to Kamal Khan, commissioner of Baltistan Division.
“They tried their best… but Miss Laura was stuck in a place which is inaccessible and the rocks were still falling at that place,” he told reporters.
Krauss, who was unharmed, descended safely to base camp and is in good health, officials said.
Dahlmeier was one of Germany’s most decorated biathletes, winning two golds and one bronze at the 2018 PyeongChang Winter Olympics. She retired in 2019 at the age of 25 and had since taken up mountaineering.
Women’s 7.5km biathlon sprint gold medalist Laura Dahlmeier, of Germany, celebrates during the medals ceremony at the 2018 Winter Olympics in Pyeongchang, South Korea, on February 11, 2018. (AP)
Tributes have poured in from across the sporting world.
“She was ambitious and successful, yet always remained humble and close to her homeland,” said Markus Soeder, premier of her home state of Bavaria.
The International Biathlon Union also expressed its condolences.
The opposition alliance Tehreek-i-Tahafuz-i-Ayeen-i-Pakistan (TTAP) on Friday called for a grand dialogue between all political parties of the country and a new charter of democracy between them.
The TTAP had held its multi-party conference on Thursday, appealing for a new social contract to restore the Constitution and democracy, claiming that government officials had blocked access to the original venue in Islamabad, forcing them to relocate. The alliance was forced to move its conference to a private farmhouse after authorities placed barriers at its intended venue, Tulip Banquet Hall.
The coalition of six opposition parties formed last year, had formalised its organisational structure last month and declared blanket support for all anti-government protests.
Addressing a press conference today on the second day of the conference held at his farmhouse, TTAP leader Mustafa Nawaz Khokhar presented the alliance’s resolution.
“The parties participating in the TTAP and its All-Party Conference (APC) agreed that at this time there is an urgent need for a new democratic charter among all political parties and political forces,” the resolution read, a copy of which is available with Dawn.com.
“As a result of the constant attacks of the hybrid system, the Constitution of Pakistan, the human rights given in it from Articles 8 to 11, and the parliamentary democratic system have become meaningless and today the social contract between the people and the state has been shattered.
“Therefore, for the new charter, a complete consensus should be reached among all the political forces in the country after a national dialogue.”
The TTAP said that political consensus was needed on the following aspects: supremacy of the Constitution and Parliament, rule of law, independence of the judiciary, appointment of a free and independent Election Commission and fair elections, the situation in Balochistan, the situation in Khyber Pakhtunkhwa and the former tribal areas, the establishment of a Truth and Reconciliation Commission, inter-provincial relations and water distribution, inter-relations of political parties and investigation of all illegal administrative actions, freedom of the media, rights of women and minorities and international relations.
Criticising yesterday’s events, the TTAP strongly condemned the conference’s cancellation at the Islamabad hotel by the administration and declared that this action was a blow to the constitutional and legal rights of citizens.
“The APC expressed deep concern over the current constitutional, political and economic situation of the country. Today, no class or nationality living in the country is satisfied, the farmers are devastated, the salaried class is under the burden of taxes and the business class is leaving the country and transferring its capital abroad.
“The poverty rate in the country has increased to an alarming level and currently about 45 per cent of Pakistan is forced to live below the poverty line and the purchasing power of the middle class has decreased by 58pc. The unemployment rate has reached an alarming level of 22pc, while the same rate among the youth is more than 30pc.
“This has never been the case in the history of Pakistan. All the participating parties of the conference decided that a comprehensive and common strategy is needed to bring the country out of the current channels,” the resolution stated.
The alliance demanded an end to the “wave of fascism and political manipulation” in the country.
It also condemned the “unjust imprisonment” of PTI founder Imran Khan and his spouse Bushra Bibi, demanding their early release and immediate appointment of their pending cases in the Islamabad High Court (IHC) and the Supreme Court for immediate hearing.
The opposition moot also lashed out at the recent sentencing against scores of PTI leaders and workers, including the National Assembly and Senate opposition leaders, saying yesterday was a “dark day in the political and democratic history of Pakistan in this regard and it once again shows that this hybrid system wants the complete elimination of the opposition in the country”.
On constitutional supremacy, the alliance criticised the recent amendments made to the Constitution and called for their removal. The moot also called for the dismantling of the Special Investment Facilitation Council, alleging that the rights and resources of the provinces were usurped through it.
Regarding the rule of law, the TTAP said that corruption in civil institutions and “undue and illegal interference by political and defence institutions” had led to a loss of public trust and undermining of professional capabilities, which was causing a deterioration in the situation of law and order in the country.
“While the justice system needs reforms, the concept of the rule of law has been severely shaken as a result of interference in the justice system, which needs to be corrected and the public’s trust restored.”
In particular, the moot said that the independence of the judiciary was reduced to a mere slogan after the 26th amendment and “kangaroo courts are now busy only in the work of cleaning up the houses of the powerful”.
The TTAP said there was an urgent need to completely abolish the 26th amendment, take direct steps to prevent all interference in the judiciary and devise an uncontroversial system of appointment of judges to purify the judiciary and restore the reputation of the institution.
“The letter of six judges of the Islamabad High Court has opened the floodgates for the demands of judicial independence in Pakistan. These judges are the heroes of the Pakistani people and we strongly condemn the actions taken against them and fully support their stand,” the alliance said, referring to the letter written by six IHC judges alleging institutional interference and pressure in judicial work.
On the security situation in Balochistan and KP, the moot said the prevailing conditions in the former were a wound for the country that needed to be urgently addressed.
“The first right to the province of Balochistan and its resources belongs to its residents … We demand that the illegally missing persons across Pakistan and especially in Balochistan be immediately brought to justice. The illegal private militias present across Pakistan, especially in Balochistan and KP, who are backed by the authorities, should be immediately dismantled and the policy of extrajudicial killings should be immediately stopped and the right to a fair trial given in the Constitution should not be deviated from in any way.
“Political prisoners, including Dr Mahrang Baloch, should be released in full. Only civil law enforcement agencies should be given responsibility for maintaining law and order. Also, immediate steps should be taken to eliminate the harassment of Baloch students studying in educational institutions across Pakistan in the name of law and order and to eliminate the hateful prejudice against them,” the resolution said.
Responding to the conference, Information Minister Attaullah Tarar dismissed it as a rote development to sabotage the economy whenever important diplomatic events were due, such as the upcoming visit of the Iranian president.
Another month has come and gone, and with it, several FDA approvals and regulatory updates related to the ever-evolving landscape of pediatric health care.
In our July monthly recap, we list our top FDA-related news items so you can stay informed in an easy-to-read and quick format.
Take a look at our detailed coverage of FDA-related news from July, and easily stay in touch with our digital newsletters that bring you practical information for today’s pediatrician.
Click the title of each story below for our full coverage of that regulatory update.
1. FDA revises labeling on extended-release stimulants for ADHD to include weight loss risk
The FDA will update labeling for all extended-release ADHD stimulants to include warnings about weight loss risk in children under aged 6 years, the agency announced in July 2025.
Though not approved for this age group, these medications are often prescribed off-label. FDA findings showed higher plasma exposure and increased adverse events, including significant weight loss, in young children taking extended-release amphetamine and methylphenidate. As a result, new Limitations of Use will be added or revised to reflect these risks, and clinicians are advised to monitor growth and consider alternative treatments when managing ADHD in this population.
2. FDA approves sebetralstat as first and only on-demand treatment for HAE
On July 7, 2025, the FDA approved sebetralstat (Ekterly; KalVista Pharmaceuticals) as the first oral, on-demand treatment for hereditary angioedema (HAE) attacks in patients 12 years and older.
Previously, HAE treatments required injection. Approval was based on the phase 3 KONFIDENT trial, which showed faster symptom relief and attack resolution with sebetralstat compared with placebo. The therapy was well tolerated and demonstrated a similar safety profile to placebo. The approval follows a delayed review and marks a significant advance in patient-controlled HAE management.
3. FDA accepts NDA for ET-600, desmopressin oral solution for pediatric AVP deficiency
On July 8, 2025, the FDA accepted Eton Pharmaceuticals’ new drug application for ET-600, an oral liquid formulation of desmopressin for treating central diabetes insipidus (AVP-D) in pediatric patients.
The NDA has a target action date of February 25, 2026. If approved, ET-600 would be the first FDA-approved oral liquid desmopressin for children, addressing dosing challenges associated with current therapies and meeting a significant unmet need in pediatric endocrinology.
4. FDA approves gardenia blue as natural color additive for food use
On July 14, 2025, the FDA approved gardenia (genipin) blue as a color additive in food, the fourth natural-source dye authorized in recent months.
The approval allows use in beverages, candies, and teas, supporting efforts to phase out synthetic, petroleum-based dyes. Derived from the gardenia fruit, gardenia blue was approved under section 721 of the FD&C Act following a petition by the Gardenia Blue Interest Group. The decision aligns with HHS’s broader initiative to prioritize natural additives and public health.
5. J&J submits icotrokinra NDA for plaque psoriasis in patients 12 years or older
On July 21, 2025, Johnson & Johnson submitted a new drug application to the FDA for icotrokinra, an investigational oral peptide targeting the IL-23 receptor, for moderate to severe plaque psoriasis in patients 12 years and older.
The submission is supported by positive results from four phase 3 trials in the ICONIC program, which showed significant skin clearance and a favorable safety profile. If approved, icotrokinra would be the first oral IL-23–targeting therapy for psoriasis, offering a new, once-daily option for patients seeking effective, noninjectable treatment.
6. FDA grants fast track designation to SGT-501 gene therapy for CPVT
On July 23, 2025, the FDA granted fast track designation to Solid Biosciences’ investigational gene therapy SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), a rare and potentially fatal inherited arrhythmia.
SGT-501 uses an AAV-based vector to deliver a functional CASQ2 gene to heart muscle cells, aiming to stabilize calcium regulation disrupted in CPVT. The therapy also holds orphan drug and rare pediatric disease designations. With no FDA-approved treatments currently available for CPVT, SGT-501 may offer a first-in-class precision approach targeting the underlying genetic cause.
7. FDA approves avatrombopag for pediatric immune thrombocytopenia, including new sprinkle formulation
On July 28, 2025, the FDA approved avatrombopag (Doptelet) for treating thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) unresponsive to prior therapy.
The approval includes a new oral granule formulation, Doptelet Sprinkle, for children aged 1 to under 6 years. Supported by phase 3 trial data, Doptelet demonstrated significant platelet response and was well tolerated. This marks the first pediatric approval for the oral thrombopoietin receptor agonist, expanding treatment options with flexible, age-appropriate formulations.
8. FDA approves sepiapterin to treat phenylketonuria in adult, pediatric patients
On July 28, 2025, the FDA approved sepiapterin (Sephience; PTC Therapeutics) to treat phenylketonuria (PKU) in both adult and pediatric patients, including infants as young as 1 month with sepiapterin-responsive hyperphenylalaninemia (HPA).
The approval, supported by phase 3 APHENITY trial data, includes broad labeling across PKU subtypes. Sepiapterin, used alongside a phenylalanine-restricted diet, significantly increased natural protein intake while maintaining blood phenylalanine control, offering a new therapeutic option that may help reduce reliance on medical formula and improve quality of life for patients across all ages.
9. FDA approves pegcetacoplan as first treatment for C3 glomerulopathy or IC-MPGN
On July 28, 2025, the FDA approved pegcetacoplan (Empaveli; Apellis Pharmaceuticals) as the first treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years and older.
The approval, based on results from the phase 3 VALIANT study, showed a 68% reduction in proteinuria and stabilization of kidney function. Pegcetacoplan also demonstrated substantial clearance of C3 deposits. This marks a significant advance for patients with these rare kidney diseases, who previously had no FDA-approved treatment options.
The actor Gary Busey has pleaded guilty to criminal sexual misconduct after admitting that he purposely touched a woman inappropriately at a horror film convention in New Jersey in 2022.
“It was not an accidental touching,” the 81-year-old Busey, who was once nominated for an Oscar, told a judge during a virtual court appearance Thursday.
In exchange for Busey’s plea, prosecutors agreed to dismiss three other counts of criminal sexual contact as well as one count of attempted criminal sexual contact. All of the charges stemmed from accusations that he groped five women with whom he was taking pictures while attending the Monster-Mania convention at a Double Tree Hilton hotel in the Philadelphia suburb of Cherry Hill, New Jersey, from 12 to 14 August 2022.
Authorities said Busey grabbed the buttocks of two women and then put his face near a third woman’s breasts while trying to unlatch her bra, as the Philadelphia Inquirer reported.
CourtTV reported that Busey’s defense attorney, Blair Zwillman, had initially argued Thursday that the indictment against her client should be dismissed because police had conducted a “faulty” investigation and failed to question certain witnesses. But Camden county, New Jersey, prosecutor Keith Carmy, contended that there was no evidence out there that would have been exculpatory for Busey and that substantial witness testimony had been presented to the grand jury which charged Busey.
The judge presiding over Busey’s case, Gwendolyn Blue, denied Zwillman. After Busey pleaded guilty, Blue tentatively set a virtual sentencing hearing for him on 18 September, CourtTV reported.
Busey reportedly faces one to five years of probation as well as fines, and he must submit a DNA sample to authorities.
He wore a hearing aid “as loud as it will go” during Thursday’s hearing, yet he evidently struggled to hear the proceeding.
Busey is known widely as a character actor with more than 100 film and television credits, generally in supporting roles. Among his credits are Point Break, Under Siege, Rookie of the Year, Lethal Weapon and Predator 2.
He earned an Oscar nomination for best actor for playing the title role in 1978’s The Buddy Holly Story.
The case to which Busey pleaded guilty on Thursday was not his first brush with the law. He faced drug charges in 1995 after a near deadly cocaine overdose sent him to the hospital.
Busey has also previously been arrested on charges of spousal abuse. And during the 2011 season of Celebrity Apprentice, he was accused of sexually assaulting a female employee of the show.
Flaco Jiménez, master of the accordion and pioneer of tejano music, has died at the age of 86.
“It is with great sadness that we share tonight the loss of our father, Flaco Jimenez,” reads a post from his family on Facebook. “He was surrounded by his loved ones and will be missed immensely. Thank you to all of his fans and friends – those who cherished his music. And a big thank you for all of the memories. His legacy will live on through his music and all of his fans.”
The cause of death is unknown but a January post from his family stated that he was “in the hospital facing a medical hurdle”.
According to his son Arturo, his last words were “Ya estoy cansado”, which translates to “I’m tired.”
Jiménez won six Grammy awards in his career, including for country instrumental performance and tejano music performance, and a lifetime achievement award in 2015. “This one, the lifetime achievement, is top of the line,” he said at the time. “You can’t go higher than that one.”
His sound was instrumental in defining tejano and conjunto music. The Guardian’s Piper LeMoine wrote that “the soundtrack of the American south-west would be incomplete” without these two genres.
“The way I learned to play the accordion was on the wild and happy side, much like Cajun and zydeco music,” he once said in an interview. “One of my early idols was Clifton Chenier. The way he played, it was like the accordion was yelling at you: hey, take this. I like to make my accordion yell and scream and make it happy.”
After performing in San Antonio in the 1960s, Jiménez went to New York City and worked with artists including Bob Dylan, Carlos Santana, Willie Nelson and the Rolling Stones.
His first solo album was released in 1972 and he would go on to record more than 25 in his career.
A tribute was paid by Cesar Rosas, a member of Los Lobos who worked with Jiménez on the song Don’t Worry Baby.
“Not only was Flaco my musical mentor, but he was also a dear friend to all of us Los Lobos,” Rosas said to the San Antonio Express-News. “He was such a musical influence on me that [he] made me run out and buy a bajo sexto and start using it in my band. He will forever be in my heart. What a tremendous loss.”
