News

BioSpace2h
FDA Issued Myeloma, Alzheimer’s Approvals in July but Rejected Two CGTs
The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla.
Ultragenyx Pharmaceutical Inc. (RARE) Gets FDA CRL for UX111, Vows Quick Resubmission
Adding to its momentum, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) recently gained Health Canada approval to expand the use ...
India Today on MSN5h
What forced Vinay Prasad to exit top job at US FDA in just 3 months
Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...
Fierce Pharma5h
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 ...
Opinion
WSJ Opinion: The FDA's Gene-Therapy Reversal and the Exit of Vinay Prasad
A top official at the Food and Drug Administration steps down after the agency changes course on a treatment for Duchenne muscular dystrophy. What does this say about the Trump Administration's ...
Why Vinay Prasad Had to Go at FDA
The gene therapy chief wanted to block fast-track drug approvals.
Public Broadcasting Service (PBS)23h
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 ...