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FDA’s Prasad Exits After Sarepta Gene Therapy Controversy
Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...
Just The News3h
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 ...
Top F.D.A. Official Resigns Under Pressure
After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...
Stocktwits on MSN11h
Why Did Sarepta Stock Jump 20% On Tuesday? Here’s What JPMorgan, Bernstein, Barclays Said About Elevidys
Shares of Sarepta Therapeutics Inc. (SRPT) traded 20% higher on Tuesday afternoon after the U.S. Food and Drug Administration ...
Sarepta shares soar 36% after FDA clears partial resumption of Elevidys shipments
Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart ...
Sarepta: SRPT Stock To $40?
This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...
BioSpace1d
FDA Does 180 on Sarepta, Freeing DMD Gene Therapy for Ambulatory Patients
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
FDA allows Sarepta to resume some Elevidys shipments
The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...
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 ...
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...
Fierce Pharma1d
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
Becker's Hospital Review1d
FDA investigates death of boy who received Sarepta gene therapy
The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...