This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

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

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...

HCA Healthcare raises 2025 profit forecast amidst insurance uncertainty while Centene anticipates a 2026 profitability boost ...

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.

Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...

As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...

Dr. Vinay Prasad, the chief scientific officer at the Food and Drug Administration, has resigned after only three months in ...

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.

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...