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

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...

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 ...

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

Roche Holding AG's H2 2025 earnings show solid growth in pharma revenues but highlight pipeline struggles and U.S. pricing ...

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.

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

Key Points Sarepta Therapeutics' most crucial product is turning out to have severe safety issues. The company's efforts to improve its situation were well received, but this victory didn't last long.

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