Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Del-zota was granted FDA breakthrough therapy designation for treating DMD, and its developer is on track to seek its ...

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

This week on "The Readout LOUD" podcast, a mother whose son has Duchenne muscular dystrophy shares her perspective on Sarepta ...

According to Endpoints News, FDA officials stated that the Center for Biologics Evaluation and Research (CBER) review staff are "unanimous" that Elevidys should never return to market. The report ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

Swiss pharma giant Roche has paused shipments of the gene therapy Elevidys (delandistrogene moxeparvovec) for new orders in certain countries outside the USA.

US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug ...

This Massachusetts-based biopharmaceutical company announced hundreds of layoffs last week. Here's what the CEO said about it ...