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STAT6d
Vinay Prasad named chief medical and science officer at FDA
Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty ...
The BMJ14h
Appointment of FDA critic Vinay Prasad to senior role in agency prompts departures
Vinay Prasad—the controversial head of vaccine regulation at the US Food and Drug Administration (FDA)—has been named FDA chief medical and scientific officer.1 Traditionally separate roles, his new ...
FDA’s Vaccine Head Adds New Chief Medical, Science Officer Roles
Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on ...
FDA's Prasad becoming agency's chief medical and scientific officer
FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...
RealClearMarkets1dOpinion
Medical Breakthroughs Will Be Few Without a Fast-Moving FDA
When Americans imagine the future, it always has a lot to do with flying cars, robot housekeepers, and just about anything ...
STAT4d
Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official
The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...
Gene Therapy Stocks Fall as FDA Pushes Out Another Top Regulator
The HHS said center directors deserve to be supported by managers aligned with aggressive goals “to expeditiously advance ...
FDA Skips Advisory Committee For Capricor's Duchenne Cell Therapy
Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.
BioSpace1d
Acting CDER Head Becomes Latest in String of FDA Leaders to Leave Agency
Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email ...
BioSpace1d
FDA Conditional Pathway Not Necessary, Rare Disease Experts Say, While Applauding Intent
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...
Investor's Business Daily on MSN4d
The FDA Shake-Up Continues, And Could Impact Genetic Medicines
The latest shake-up at the FDA forced out the top two officials in charge of reviewing cell and gene therapies, analysts said ...
FDA opens fast-track review process for national health priorities
The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers ...