EMA’s CHMP issued an opinion not to recommend Elevidys™ (delandistrogene moxeparvovec) for the treatment of ambulatory individuals with Duchenne muscular dystrophy (DMD) Roche will continue its ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

The Swiss pharmaceutical group said the negative opinion from the European Medicines Agency was based on data that included a phase 3 study in which Elevidys didn't meet its primary endpoint after one ...

Friday said that the European Medicines Agency has issued a negative opinion on the conditional marketing authorization for Elevidys, intended for ambulatory patients aged three to seven with Duchenne ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Roche Holding AG’s gene therapy Elevidys failed to get the backing of European regulators.The European Medicines Agency’s drug advisory committee recommended against Elevidys for children with ...

Intel (NASDAQ: INTC) stock slumped 8% after the chipmaker forecast steeper losses than expected in the third quarter and ...

Results show biopsy-proven resolution of BK polyomavirus nephropathy in kidney transplant recipients No safety or ...