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The FDA’s top vaccine and gene therapy official resigned amid heightened scrutiny over recent drug approval decisions and ...
GlobalData on MSN12h
Prasad’s FDA exit may accelerate cell and gene therapy approvalsVinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), ...
TipRanks on MSN8h
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy UseShares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
After turning down several new drugs and restricting use of another, Dr. Vinay Prasad drew the ire of the right-wing ...
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...
Stocktwits on MSN3h
Replimune Stock Catches Retail Fire As Analyst Says FDA Shakeup Removes 'Major Obstacle' For Skin Cancer Drug's Potential ApprovalRetail trader buzz around Replimune Group surged Wednesday after Cantor Fitzgerald upgraded the stock to ‘Overweight’ from ...
Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...
Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.
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