News

The Pharma Letter1h
The week in pharma: action, reaction and insight – week to July 25
Last week, a US Food and Drug Administration (FDA) advisory committee (AdCom) voted against approval of Danish drugmaker ...
Notable healthcare headlines for the week: Pfizer, UnitedHealth, Sarepta and Thermo Fisher in focus
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 ...
GEN - Genetic Engineering and Biotechnology News1h
FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys
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 ...
Medical Dialogues3h
Roche gets negative EMA Committee opinion on Elevidys CMA for 3-7 year olds with Duchenne muscular dystrophy
Basel: Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Precision Medicine Online15h
FDA Investigating Death of Boy in Brazil Treated With Sarepta's Duchenne Gene Therapy
Sarepta maintains it reported the incident to the FDA in June, and the boy's doctor had deemed his death was unrelated to treatment.
FDA opens probe into mysterious death linked to gene therapy
The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...
What’s behind Sarepta’s gene therapy deaths?
Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...