News

493 employees laid off at biopharmaceutical company with operations in Andover
A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the industry leaders in gene therapy goes through a “strategic restructuring.” Sarepta ...
STAT4h
What Vinay Prasad’s ouster means for biotech and the FDA
This week on "The Readout LOUD," STAT's biotech reporters parse what Vinay Prasad's ouster means for biotech and the FDA.
The American Journal of Managed Care12h
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 Pharma12h
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 ...
News4JAX1d
FDA vaccine chief leaving 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.
BioWorld1d
In Broadway trial, a hopeful tune for Alzheimer’s prevention
At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...
STAT1dOpinion
Vinay Prasad was not good for the FDA. But his ouster makes things worse
Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But ...
Devdiscourse1d
Vinay Prasad's Controversial Exit from the FDA
Vinay Prasad, appointed as FDA's top vaccine official, faced criticism and backlash during his short tenure. Controversies surrounded gene therapy safety and regulatory decisions affecting futures of ...
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 ...
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 ...
The New York Sun1d
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 ...
BioSpace1d
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 ...