Fda

• Kyle Diamantas, un alto funzionario dell'agenzia, sostituirà presumibilmente Makary e ricoprirà il ruolo di commissario ad interim della FDA • Marty Makary si è dimesso martedì dalla carica di commissario della US Food and Drug Administration (FDA), concludendo un mandato di 13 mesi presso l'agenzia regolatoria che ha spesso attirato l'ira della Casa Bianca, del Congresso, dell'industria e dell'opinione pubblica, secondo i resoconti dei media statunitensi. • Kyle Diamantas, che in precedenza ha lavorato come massimo responsabile alimentare dell'agenzia definendo la direzione strategica e le operazioni per la politica alimentare negli Stati Uniti, è stato indicato come sostituto ad interim di Makary, secondo quanto riportato da Politico, che ha dato per prima notizia delle dimissioni e della sostituzione di Makary. Anche Reuters e NBC News hanno riportato le dimissioni di Makary.

Le decisioni del commissario della Food and Drug Administration hanno danneggiato il morale dello staff e messo a rischio il suo posto di lavoro

• FDA announced new enforcement actions targeting compounding pharmacies producing GLP-1 drugs like semaglutide amid safety concerns. • The crackdown addresses risks from unapproved versions of weight-loss and diabetes medications flooding the market. • This policy shift aims to protect patients from potential contamination and dosing errors in the booming $100 billion GLP-1 sector.

Serious side effects from vaccines were rare, scientists found in studies funded by US taxpayer moneyThe US Food and Drug Administration has blocked the publication of several studies that found Covid-19 and shingles vaccines to be safe, according to a spokesperson from the Department of Health and Human Services.Agency scientists conducted the studies by analyzing millions of patient records and found that serious side effects from the vaccines were rare, the spokesperson confirmed. The studies – funded by taxpayer money and costing several million dollars – included research examining the safety of Covid-19 vaccines in 2023 and 2024. Continue reading...

• President Trump issued an Executive Order directing the Department of Health and Human Services to expedite access to treatments for patients with serious mental illness. • The FDA is accelerating its review process for mental health therapies in response to the directive. • This policy shift aims to reduce barriers to treatment approval and expand therapeutic options for affected patients.

• The FDA announced the first ibogaine investigational new drug application as part of Trump's mental health executive order accelerating psychedelic drug approvals and research pathways. • HHS will coordinate with the FDA and DEA to expedite research approval and clinical trial access for emerging mental health treatments under strict medical supervision and scientific oversight. • The initiative specifically targets treatment-resistant conditions and addresses mental health needs among veterans and patients who have not responded to conventional therapies.

• The FDA announced it will issue national priority vouchers for three psychedelic drugs next week, marking the first time the agency has fast-tracked any psychedelics for review under Trump's executive order on mental health reform. • The vouchers can compress FDA review timelines from several months to just weeks, according to FDA Commissioner Marty Makary, if the drugs align with national priorities. • Trump's order directs $50 million in federal funding to states developing psychedelic treatment programs and establishes a federal-state partnership for technical assistance and data sharing.

• FDA ties multistate E. coli outbreak sickening multiple individuals to cheese made with unpasteurized raw milk. • Highlights risks of raw dairy products in public health alerts. • Investigation ongoing to prevent further cases amid rising food safety concerns.

• Elijah Dottery, diagnosed with sickle cell anemia as a baby, became the first U-M patient to receive the newly FDA-approved stem cell therapy. • The treatment uses patient's own stem cells edited via CRISPR to produce functional hemoglobin, administered at Michigan Medicine. • This breakthrough matters for over 100,000 U.S. sickle cell patients, offering potential cure where prior therapies only managed symptoms.

Researchers say ‘magic mushrooms’ can help with traumatic symptoms, but urge caution as states expand accessSign up for the Breaking News US email to get newsletter alerts in your inboxAfter three combat deployments in Afghanistan, during which he suffered traumatic brain injuries from concussive blasts, army ranger Jesse Gould developed post-traumatic stress disorder and said he “drank almost every night to cope”.In times of hardship, veterans sometimes turn to “medication and talk therapy, but it tends to be more of a maintenance program than actually overcoming it”, Gould said, but added that at age 38, “I was still very young. I didn’t want to be on medication the rest of my life.” Continue reading...

• FDA has approved an investigational new drug application for synthetic CAR-T (sCAR-T) therapy targeting autoimmune conditions. • The clearance enables clinical trials to test this engineered cell therapy in US patients with refractory autoimmune diseases. • sCAR-T represents a novel approach adapting cancer immunotherapy for immune disorders, potentially offering durable remissions.

• FDA approved Haleon's Narcan 4mg nasal spray for non-prescription sale on April 7, 2026, building on 2023 authorization. • Reversal success rate 98% in trials with 150 US overdose simulations; priced at $29.95 for two-pack. • Addresses 110,000 annual US opioid deaths; 'Lifeline for bystanders,' says FDA Commissioner.

• The FDA granted approval on April 7, 2026, to Moderna's mRESVIA vaccine, an mRNA-based shot targeting respiratory syncytial virus (RSV) for adults aged 60 and older. • Clinical trials showed 83.7% efficacy against RSV lower respiratory tract disease in the first season, with data from over 37,000 participants across 22 countries including US sites. • This marks the second mRNA RSV vaccine approved after GSK's Arexvy, aiming to reduce 140,000-160,000 annual US hospitalizations among seniors; CDC review expected soon.

• Artivion (AORT) secured U.S. FDA approval for the NEXUS Aortic Arch System on April 7, 2026. • The device approval is expected to accelerate hospital adoption and spark reimbursement discussions. • This milestone positions Artivion for revenue growth in cardiovascular treatments.

• The FDA has awarded breakthrough device designation to more than 1,200 experimental devices, including AI innovations, since 2016. • Evolving FDA criteria reflect accelerating AI integration in US health tech approvals. • Program speeds market access for transformative devices addressing unmet medical needs.

• FDA announced on April 1, 2026, that new drug approvals last year reached near-record levels, surpassing five-, ten-, and multi-year averages. • This update highlights continued acceleration in innovative therapies reaching US patients, boosting treatment options for various diseases. • Strong approval momentum underscores FDA's commitment to expediting safe, effective drugs amid public health priorities like cancer and rare diseases.

• The FDA approved the first RSV vaccine for infants via maternal immunization on March 18, 2026, allowing pregnant women to receive vaccination in the third trimester to confer passive immunity to newborns. • The approval is based on a Phase 3 trial showing 82% efficacy in preventing severe RSV disease in infants under six months, with passive immunity lasting approximately three months post-birth. • RSV causes approximately 100,000 hospitalizations and 300-400 deaths annually among US infants, making this vaccine potentially transformative for preventing severe respiratory illness in the most vulnerable population.

• The FDA issued an urgent safety alert on March 20, 2026, warning of counterfeit versions of semaglutide and tirzepatide circulating through unverified online retailers, with 47 adverse events reported including severe infections and allergic reactions. • Counterfeit products lack sterility assurance and may contain contaminated ingredients or incorrect dosing, posing serious health risks to consumers seeking weight loss or diabetes treatment. • The agency recommends patients obtain GLP-1 medications only through licensed pharmacies with valid prescriptions, emphasizing that legitimate suppliers require medical supervision.

• The FDA granted accelerated approval to a novel immunotherapy combination for metastatic pancreatic cancer on March 21, 2026, based on Phase 2 trial data showing a 35% response rate. • The drug combination demonstrated a median overall survival of 14.2 months compared to 11.8 months with standard chemotherapy in the clinical trial of 280 patients. • Pancreatic cancer remains one of the deadliest cancers with a five-year survival rate below 12%, making this approval potentially significant for the estimated 64,000 Americans diagnosed annually.

• Democrats laying groundwork for major U.S. health care reforms amid political shifts in Washington. • NIH's Bhattacharya commits to full budget spending; top FDA official announces exit. • Moves signal potential policy battles over research funding and regulatory changes.

• Johnson & Johnson has received FDA approval for a new psoriasis treatment pill, expanding therapeutic options for patients with the chronic skin condition. • The United States smoking rate has quietly reached a historical low, reflecting decades of public health efforts and tobacco control policies. • These developments represent significant milestones in pharmaceutical innovation and public health outcomes across different therapeutic areas.

• The FDA linked Raw Farm's raw cheddar cheese to seven E. coli O157:H7 cases across multiple states, a strain causing severe kidney issues, hospitalization, or death. • Producer declined recall of two products despite Sunday's FDA alert on March 16. • Outbreak underscores risks of raw milk products, prompting public warnings to avoid consumption.

• The FDA on March 13 expanded approval of GSK's Arexvy RSV vaccine to adults aged 18-49 at increased risk of lower respiratory tract disease. • Phase 3b trial data showed non-inferior immune response in younger adults compared to those 60+, targeting 21 million U.S. adults under 50 with conditions like diabetes or obesity. • RSV causes 17,000 hospitalizations, 277,000 emergency visits, and 2 million outpatient visits yearly in this group, highlighting need for broader protection amid rising cases.

• Telix Pharmaceuticals resubmitted its New Drug Application to the U.S. FDA on March 16, 2026, for TLX101-Px (Pixclara®), a PET imaging agent targeting gliomas in adults and pediatrics. • The agent received Orphan Drug and Fast Track designations from the FDA due to its potential to address unmet needs in post-treatment glioma management, with 18F-FET PET already in international guidelines but no U.S.-approved equivalent. • Glioblastoma multiforme (GBM), the most common aggressive primary brain cancer, affects about 22,000 new U.S. cases yearly, with recurrence nearly universal and median survival of 12-15 months post-diagnosis.

An FDA advisory committee has recommended the development of next year's flu vaccine, as new data from the CDC indicates the current 2025-2026 flu vaccine provides moderate protection against hospitalization for vaccinated individuals despite concerns about late-emerging H3N2 strains. The committee reviewed winter flu shot effectiveness reports published in the CDC's online MMWR journal, which showed moderate protective efficacy against severe outcomes requiring hospitalization. The timing of vaccine selection remains critical as late-emerging H3N2 variants can significantly undermine vaccine effectiveness, a concern flagged by the committee during this year's review. Current guidance continues to emphasize vaccination for those at high risk of severe illness, particularly elderly and immunocompromised populations.