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 ...

Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker ...

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

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 ...