News

Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...
Fierce Pharma2d
FDA mulls Elevidys market withdrawal following 3rd death after a Sarepta gene therapy
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...
BioPharma Dive4d
Moderna’s latest approval again reveals FDA rift over COVID vaccines
Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...
Hays Post15d
FDA official restricted COVID vaccine approvals against the advice of agency staff
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and ...
Science-Based Medicine16d
Dr. Vinay Prasad: Bodily Autonomy Applies to Raw Milk, Not Vaccines
Dr. Vinay Prasad: Bodily Autonomy Applies to Raw Milk, Not Vaccines This is what it looks like when disinformation doctors pretend to value data and science to further their true objective, MAHA ...
WKRG17d
FDA official restricted COVID vaccine approvals against staff advice
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.
WLNS.com17d
FDA official restricted COVID vaccine approvals against staff advice
The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots.