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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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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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Report says Jim O'Neill's time at HHS is nearing its end

HHS Deputy Secretary Jim O'Neill – who is also head of the CDC – is said to be on the way out after a reshuffle of department leadership by RFK Jr.

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FDA says comparator dose scuppered Moderna's flu jab filing

The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.

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Moderna cries foul as FDA blocks filing of mRNA flu shot

The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.

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

NIH Director Bhattacharya will temporarily run CDC

FDA relents and will review Moderna's flu shot

Report says Jim O'Neill's time at HHS is nearing its end

FDA says comparator dose scuppered Moderna's flu jab filing

Moderna cries foul as FDA blocks filing of mRNA flu shot

LSX2026: On promise and patience, with Hans Schambye

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