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Amid staff cuts, FDA looks to AI to 'optimise' reviews

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' chief executive Reenie McCarthy

Axe falls on Stealth Bio staff after FDA rejects lead drug

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 pull HER3-DXd's FDA filing

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

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Eisai says patent win blocks Lenvima generic to 2036

Eisai has won a lawsuit blocking FDA approval of Shilpa's generic of cancer blockbuster Lenvima until 2036, although the verdict could go to appeal.

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Manufacturing issues scupper Savara's lead drug filing

Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.

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CDC stops backing COVID jabs for pregnant women, children

In a new sign of downgraded support for COVID-19 shots by the US administration, the CDC has stopped backing vaccines for pregnant women and children.

Amid staff cuts, FDA looks to AI to 'optimise' reviews

Axe falls on Stealth Bio staff after FDA rejects lead drug

MSD and Daiichi Sankyo pull HER3-DXd's FDA filing

Eisai says patent win blocks Lenvima generic to 2036

Manufacturing issues scupper Savara's lead drug filing

CDC stops backing COVID jabs for pregnant women, children

Novo sues Lilly over 'misleading' GLP-1 ad campaigning

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

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