Tag Archives: FDA

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics said late Friday it won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient receiving one of its treatments for muscular dystrophy. The highly unusual move is a latest in a string of events that have hammered the …

Sarepta says it won’t comply with FDA request to stop shipping gene therapy Elevidys  Reuters Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times Sarepta shares plunge 40% as future of its gene therapy appears at risk  CNBC Third death from a Sarepta gene therapy  biocentury.com We are mothers of Duchenne patients. Recent setbacks with Sarepta must not …

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. Sarepta last month paused shipments for certain older Duchenne patients following the death from acute liver failure of a second teenager treated with the therapy, called Elevidys. The …

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says  Reuters Sarepta shares plunge 40% as future of its gene therapy appears at risk  CNBC FDA to Ask Sarepta to Stop Shipping Muscular Dystrophy Drug Elevidys  The New York Times Third death from a Sarepta gene therapy  BioCentury FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market  Bloomberg …

Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023. Michael Nagle | Bloomberg | Getty Images Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk. The Food and Drug Administration will …

FDA panel backs menopausal hormone therapy  Axios F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments  The New York Times FDA chief: HRT warning among ‘greatest mistakes of modern medicine’  NewsNation FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women  fda.gov US could scrap health warnings on HRT  The Telegraph Source link

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.45. In a surprise, advisers to the Food and Drug Administration on Thursday voted that the risks tied to a blood cancer drug from GSK outweighed the benefits it had demonstrated in trials, as concerns about sometimes serious eye-related side effects and …

Juul Labs can continue to sell its e-cigarettes and refill cartridges per a decision Thursday by the Food and Drug Administration. According to an announcement on Juul’s website, the FDA determined that its e-cigarette device and pods — which come in tobacco and menthol flavors — are “appropriate for the protection of public health.” Thursday’s authorization, first reported by The …

Exclusive | FDA Authorizes Juul E-Cigarettes  The Wall Street JournalView Full Coverage on Google News Source link