News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News Makary says FDA will "end two-trial dogma" for approvals The FDA plans to adopt a new policy that will do away with the default requirement to base regulatory filings for new medicines on two pivotal trials.
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 FDA approves higher Wegovy dose via 4th priority voucher The US FDA has approved a fourth product via its new National Priority Voucher Programme -- a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy (semaglutide), to be marketed as Wegovy HD.
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