News

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Fierce Pharma21h

FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

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.

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 ...

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

US FDA approves PTC Therapeutics' metabolic disorder drug

The U.S. Food and Drug Administration has approved PTC Therapeutics' oral drug to treat a rare inherited metabolic disorder ...

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
The Pharma Letter9h

FDA lifts shipping pause for Elevidys in ambulatory DMD patients

Sarepta Therapeutics (Nasdaq: SRPT) has been cleared by the American medicines regulator to resume shipments of its gene ...
BioSpace7d

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...
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 ...
TipRanks on MSN1d

FDA probing death of 8-year-old boy who received Sarepta’s Elevidys

The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene ...