News

Public Broadcasting Service (PBS)1h
Controversial FDA vaccine chief departs agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...
Healio2h
Oncologist who served as FDA’s chief medical officer, top vaccine official departs agency
A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...
STAT3h
STAT breaks down the confusing, heartbreaking Sarepta saga
In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...
The New York Sun4h
FDA’s Top Regulator Is Out Amid MAHA Backlash Over Blocking Access to a $3.2 Million Per Dose Therapy for Rare Disorder in Boys
Vinay Prasad, who came under fire from patient advocacy groups and Laura Loomer, is gone after less than three months on the ...
BioSpace4h
Exit Stage Right: With Prasad Out, Analysts Hope for More Traditional Replacement
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...
Stocktwits on MSN16h
FDA Official Who Halted Sarepta’s Gene Therapy Resigns Amid Backlash Over Access To Duchenne Treatment
Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing ...
Opinion
On Sarepta, a Welcome FDA Reversal
After our editorial, the agency relents to allow a Duchenne treatment.
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers
Sarepta stock sees upgrades and price hikes as analysts reassess Elevidys prospects following a favorable FDA development.
Becker's Hospital Review1d
Death of 8-year-old not tied to Sarepta gene therapy: FDA
The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...
Precision Medicine Online1d
Sarepta Stock Rebounds as it Resumes Shipments of Duchenne Gene Therapy for Some Patients
The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.