News

The American Journal of Managed Care1h
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Fierce Pharma1h
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
STAT22h
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 ...
Amazon S3 on MSN20h
The story of Sarepta's Duchenne gene therapy
The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The ...
Trump Straight Up Ignored RFK Jr. to Fire Top Vaccine Regulator
Donald Trump reportedly ignored calls from Health Secretary Robert F. Kennedy Jr. not to fire the top vaccine official at the Food and Drug Administration after a pressure campaign from far-right ...
Why Trump ordered ouster of FDA official
The former official, Vinay Prasad, had been on the job three months and had recently come under attack by conservative ...
GlobalData on MSN20h
Prasad’s FDA exit may accelerate cell and gene therapy approvals
Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...
Top FDA Official’s Surprise Departure Means More Uncertainty for Biotech
A spokesperson for the Department of Health and Human Services confirmed that Dr. Vinay Prasad, who led the FDA’s Center for ...
Trump drove firing of FDA official
The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.
PharmExec22h
Vinay Prasad’s FDA Departure Follows Controversy Over Drug Rejections
The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...
Senate confirms CDC director as top FDA official resigns under political pressure
In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...
BioSpace22h
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 ...