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TipRanks on MSN5h
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
FDA vaccine chief leaving agency after less than 3 months
The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...
BioSpace8h
New CDER Head Tidmarsh Will Sub In At Biologics Group After Prasad’s Exit
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...
Amazon S3 on MSN8h
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 ...
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), ...
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 ...
PharmExec10h
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 ...
STAT10h
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 ...
STAT11h
Trump administration reverses course, lifts pause on NIH grant awards
The order applies to the entirety of new and, possibly, ongoing research grant dollars that go to universities and academic ...
The New York Sun11h
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 ...
BioSpace11h
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 ...
US FDA's top vaccine official Vinay Prasad leaves agency after 3 months
The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...