U.S. FDA · Santé
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U.S. FDA fait partie des 400+ fils de presse que PPN World surveille en continu — un fil en anglais axé sur le secteur Santé, classé sous « États-Unis » dans notre index par pays. Chaque communiqué est dédupliqué, géolocalisé et enrichi d'un résumé IA, et vous pouvez y attacher des alertes sur recherches enregistrées.
- FDA Approves First Gene Therapy for Young Children with Sickle Cell Diseaseil y a 7 j
The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurre…
- FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patientsil y a 8 j
The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patien…
- FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturingil y a 9 j
FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufactur…
- FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Healthil y a 13 j
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to effi…
- FDA Approves First Single-Dose Generic Treatment for Influenzail y a 21 j
The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in pat…
- FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdoseil y a 23 j
The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency…
- FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetesil y a 23 j
On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages…
- FDA Clears First Over-the-Counter Continuous Glucose Monitor for Childrenil y a 26 j
The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integ…
- FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Catsil y a 28 j
FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kitt…
- FDA Expands Sunscreen Options for the First Time in 20 Yearsil y a 30 j
Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen inno…
- FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patientsil y a 37 j
The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and…
- FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugsil y a 41 j
The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
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