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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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NICE backs changes to NHS' diabetes care pathway

New guidance from NICE on type 2 diabetes management will shake up NHS treatment, with wider use of both SGLT2 inhibitors and GLP-1 agonists.

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NIH Director Bhattacharya will temporarily run CDC

The long months without stable leadership at the CDC in the US look set to continue, as NIH chief Jay Bhattacharya is named acting director.

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FDA relents and will review Moderna's flu shot

The FDA will start a review of Moderna's flu jab mRNA-1010, after refusing to accept the filing last week, with a new "regulatory approach."

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FDA starts review of BMS's 'celmod' for multiple myeloma

Bristol Myers Squibb could be months away from bringing the first 'celmod' to market, as the FDA starts a review of iberdomide for multiple myeloma.

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NICE backs first disease-modifying drug for ARG1 deficiency

Immedica's Loargys is poised to become the first NHS therapy for ultra-rare genetic disorder ARG1 deficiency that can alter the course of the disease.

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

NICE backs changes to NHS' diabetes care pathway

NIH Director Bhattacharya will temporarily run CDC

FDA relents and will review Moderna's flu shot

FDA starts review of BMS's 'celmod' for multiple myeloma

NICE backs first disease-modifying drug for ARG1 deficiency

Pharvaris plans filings for HAE drug after pivotal trial win

Discover a new era of healthcare panel engagement: Grounded ...

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