News

Controversial FDA official Dr. Vinay Prasad departs agency
Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory ...
Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy
Dr. Vinay Prasad has resigned from the FDA after less than three months amid controversy over Sarepta Therapeutics' gene therapy and pressure from the White House. He plans to return to California to ...
Vinay Prasad, US FDA's chief medical and science officer, departs agency
Vinay Prasad, the Food and Drug Administration's chief medical and science officer, resigned. He cited a desire to return to ...
The New York Sun4h
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Dr. Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on ...
BioPharma Dive6h
Vinay Prasad, controversial FDA official, abruptly departs agency
Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...
Just The News7h
FDA allows distribution of muscular dystrophy drug again after public criticism
The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...
BioSpace7h
Prasad Out at CBER Following Sarepta Rollercoaster and Conservative Criticism
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, ...
Top F.D.A. Official Resigns Under Pressure
After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...
BioWorld11h
Apellis’ Empaveli approved in US for two rare kidney diseases
The approval to reduce proteinuria for those 12 and older with either of the two severe and rare kidney diseases came on the July 28 PDUFA date, a little more than four years after the company won ...
Sarepta soars after FDA says some patients can get Elevidys
Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
Sarepta Therapeutics, Inc. (SRPT): “You Don’t Court Homicide,” Says Jim Cramer
We recently published 11 Stocks That Jim Cramer Recently Talked About. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is one of the ...