regulatory

News

RFK Jr has removed all 17 members of the CDC's vaccine advisory committee in a move that some fear could lead to restrictions on immunisation access.

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Wockhardt has completed a pre-filing meeting with the FDA and is preparing to submit its novel antibiotic Zaynich in the US and Europe.

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With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.

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The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.

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Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.

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MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.