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 ...

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

Currently, a multidistrict litigation against Pfizer (NYSE: PFE) is underway on behalf of women who claim to have developed meningiomas after receiving four or more consecutive injections of ...

Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

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

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

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