Dr Martin Makary

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Scrabble lettering of Two and One on grass

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.

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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.

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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.

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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.

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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.

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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.

Makary says FDA will "end two-trial dogma" for approvals

Antibiotic is first approval in FDA national priority scheme

GLP-1s feature in second batch of national priority vouchers

FDA hands out first national priority vouchers to nine firms

FDA will review abortion pill safety – will it be impartial?

Vinay Prasad returns to FDA

Novartis CEO joins board of "responsible" AI firm Anthropic

Using AI-driven synthetic personas to take your insights fur...

Dr Martin Makary

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