News Reports: Makary out, Diamantas in as FDA commissioner According to multiple press reports citing anonymous insider sources, Dr Marty Makary has resigned after a year at the head of the FDA.
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 Antibiotic is first approval in FDA national priority scheme FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.
News GLP-1s feature in second batch of national priority vouchers GLP-1 drugs for weight loss, cancer, and rare diseases feature among the latest crop of medicines awarded priority vouchers by the FDA.
News FDA hands out first national priority vouchers to nine firms The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher programme.
News FDA will review abortion pill safety – will it be impartial? The Trump administration's linking of autism to Tylenol and vaccines with no evidence raises concern about an FDA review of mifepristone's safety.
News Major trial launched to explore GLP-1 benefit in dementia A $100m trial has been launched to see if lifestyle changes coupled with GLP-1 agonists or similar incretins can reduce the risk of dementia.
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