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India Today on MSN3h

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 Pharma3h

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 ...

Gene Therapy Market Fueled By CRISPR Advances & Regulatory Momentum Datam Intelligence

Gene Therapy Market Gene therapy market surges on breakthroughs in genome editing, rising chronic & genetic disease cases, regulatory appro ...
TipRanks on MSN18h

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 ...
PharmTech21h

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.

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), ...
PharmExec23h

IGNYTE Trial Investigators Press FDA to Reconsider Replimune CRL Amid Promising Melanoma Data, Leadership Shakeup

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 ...
PharmExec23h

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 ...