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

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

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

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

Roche has halted some international shipments of the gene therapy Elevidys, used to treat Duchenne muscular dystrophy, Bloomberg reported July 22. The decision comes in the wake of a similar move by ...

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

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

For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its ...

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 ...

Roche (RHHBY) plans direct-to-patient drug sales in the U.S. to avoid the influence from pharmacy benefit managers in product ...

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched ...