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

Sarepta Therapeutics (SRPT) shares dropped sharply on Monday following news that the FDA is investigating a patient death potentially connected to its gene therapy, Elevidys.

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

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

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.

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 ...

(RTTNews) - European stocks closed on a strong note on Wednesday amid rising expectations that the European Union and the U.S. will strike a trade deal before the newly announced deadline of August 1.

Then, on April 4, 2025, Sarepta disclosed that European Union member country authorities had requested that the independent data monitoring committee meet to review death announced on March 18, 2025.

Why is greater novel food market access important? Novel foods are defined by the EU as foods that were not significantly consumed within the bloc before May 15, 1997. In order to enter the market, ...

News State Board of Education prepares for courtroom challenges to vaccination policies, regulatory authority By Brad McElhinny July 2, 2025 - 2:43 pm (Pixabay) ...

GetYourGuide CEO Johannes Reck blasted reports that the U.S. and the European Union are close to an agreement that would weaken the DMA.