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 ...

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

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 ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has earned a $100 million milestone payment from ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

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Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

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

Abivax dazzled investors and analysts with positive data from a pair of Phase III induction trials assessing obefazimod in adults with moderately to severely active ulcerative colitis. The results ...