Credit: Getty Images. Regulatory action is expected on May 29, 2023. The Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee voted 8 to 6 in support of ...
In an eagerly anticipated decision, the Food and Drug Administration Thursday approved the first gene therapy for muscular dystrophy. "Today's approval addresses an urgent unmet medical need and is an ...
CHARLESTOWN, Mass., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular ...
Sarepta Therapeutics Inc. (NASDAQ: SRPT) jumped nearly 31% on May 15, after a Food and Drug Administration committee gave a thumbs up to the company’s experimental gene therapy to treat Duchenne ...
WASHINGTON (AP) — Shares of Sarepta Therapeutics plunged Monday after the biotech drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. Sarepta reported the ...
The Food and Drug Administration is convening a meeting of outside experts on Friday to review clinical data on an experimental gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics.
INDIANAPOLIS — A local mom is pushing for a rare and deadly disease to be added to Indiana's newborn screening panel. Duchenne muscular dystrophy affects at least 1 in 5,000 male births each year.
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