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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 ...
Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.
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 ...
For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its ...
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 ...
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
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