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 ...

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

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 valuation cuts.

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

Precision BioSciences (NASDAQ:DTIL) saw its stock rise 5% following the announcement that the U.S. Food and Drug ...

Shares of Cambridge, Mass.-based Sarepta have fallen by more than 90% in the last year amid safety concerns about its Elevidys, a gene therapy that treats Duchenne muscular dystrophy, following ...

In line with its aim to provide decisions within one business day on at least 95% of prior authorizations by next year, Humana will cut a third of its prior authorization requirements. It will also ...

Sarepta Therapeutics (SRPT) stock is back in focus as Roche (RHHBF) pauses global shipments of its Elevidys gene therapy ...

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...