News

Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy
Dr. Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene therapy and pressure from the White House. He plans to return to California to ...
The New York Sun4h
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Dr. Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on ...
Just The News7h
FDA allows distribution of muscular dystrophy drug again after public criticism
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
BioSpace7h
Prasad Out at CBER Following Sarepta Rollercoaster and Conservative Criticism
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...
Sarepta soars after FDA says some patients can get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.
Sarepta shares rebound after shipments of gene therapy Elevidys resume in US
Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...
Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
Shares of Sarepta surged Tuesday, a day after the FDA said the company could lift a voluntary pause on shipments of its Elevidys drug, which had been linked to three patient deaths this year. The ...
Becker's Hospital Review19h
Death of 8-year-old not tied to Sarepta gene therapy: FDA
The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...
Sarepta Therapeutics Stock Surges as FDA Allows Elevidys Sales to Resume
Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.