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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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PTC pulls file for Duchenne therapy on FDA feedback

PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.

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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.

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Amgen baulks at FDA request to withdraw Tavneos

Amgen confirmed on its fourth-quarter results call that it has resisted a request to pull Tavneos for ANCA-associated vasculitis from the US market.

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FDA knocks back Pharming's bid for wider Joenja use

The FDA has turned down Pharming's bid to broaden the label of Joenja for rare immunodeficiency disorder APDS so it can be used in younger patients.

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

PTC pulls file for Duchenne therapy on FDA feedback

FDA says comparator dose scuppered Moderna's flu jab filing

Moderna cries foul as FDA blocks filing of mRNA flu shot

Amgen baulks at FDA request to withdraw Tavneos

FDA knocks back Pharming's bid for wider Joenja use

LSX2026: On promise and patience, with Hans Schambye

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