News

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...
MPR2h
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.
MedPage Today1h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
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 ...
Cambridge pharma company lays off almost 500 amid FDA dispute over treatment
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
BioPharma Dive1h
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Stocktwits on MSN15h
GlucoTrack, Sarepta, TNF Pharma Dominate Weekly Retail Health Care Buzz — Here’s Why
Retail chatter spiked last week as investors piled into three healthcare stocks: GlucoTrack, Sarepta Therapeutics, and TNF ...
MyChesCo on MSN1h
FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure
The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular ...
Precision Medicine Online3h
Sarepta to Continue to Ship Duchenne Gene Therapy Elevidys Despite FDA Request
The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.
Fierce Pharma3h
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
Sarepta slides as FDA places clinical hold on gene therapy clinical trials
Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.
STAT15mOpinion
The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...