From Hope to Proof: How Prasad’s FDA Could Reshape Biotech Approvals

When Dr. Vinay Prasad was abruptly removed from his FDA post earlier this summer, many in the biotech industry breathed a sigh of relief. Prasad had a reputation as a stringent critic of lax drug approvals and had begun pressing pause on a high-profile gene therapy amid safety concerns. But now, less than two weeks later, he’s back – reinstated as head of the FDA’s Center for Biologics Evaluation and Research (CBER) at the request of the agency. This whiplash reversal has industry observers parsing what it means for the future of oncology drug reviews, gene therapy oversight,

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