News FDA set to raise bar for clinical trials of CAR-T therapies The FDA could make it harder for developers of CAR-T therapies to bring them to market by requiring full randomised controlled trials.
News Is FDA about to restrict vaccination even further? Vinay Prasad, head of CBER, is reported to be planning to tighten regulations on vaccines after concluding that COVID-19 shots caused 10 child deaths.
News FDA unveils swift route to market for personalised drugs FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.
News Vinay Prasad returns to FDA In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.
News Vinay Prasad abruptly departs from the FDA The disruption at the FDA continues with the departure of CBER director Vinay Prasad, less than three months after taking on the role.
News Makary, Prasad set out their vision for the FDA Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."
News Kyverna rises on stiff person syndrome data Kyverna hopes to file CAR-T therapy miv-cell for approval as the first therapy for stiff person syndrome, a rare and debilitating autoimmune disease.
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