The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.

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 ...

The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...

Sarepta maintains it reported the incident to the FDA in June, and the boy's doctor had deemed his death was unrelated to treatment.

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...

Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

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

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

The U.S. FDA is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene therapy for Duchenne ...

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