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FDA’s Prasad Exits Following Political Backlash Over Sarepta
Vinay Prasad, a top regulator at the US Food and Drug Administration, left the agency after a short-lived tenure that ended ...
BioSpace17m
Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s Alzheimer’s Comeback and Q2 Earnings
Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task ...
STAT1d
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
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 ...
Dr Vinay Prasad's FDA exit in less than 3 months linked to Sarepta gene therapy controversy? Check details
Dr. Vinay Prasad, a controversial figure and critic of the FDA, resigned from his high-ranking position at the agency after ...
Just The News10h
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 ...
Fierce Pharma1d
FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients
Sarepta Therapeutics shares are halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...
STAT11d
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
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 Therapeutics says it will pause shipments of Duchenne gene therapy
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...