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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.

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Autolus closes on EU okay for leukaemia cell therapy

The CHMP backed approval of Autolus' leukaemia CAR-T Aucatzyl, as well as drugs from GSK, Roche, SpringWorks, and others, at its May meeting.

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NICE relents and backs drug for IgAN from CSL Vifor

Thousands of people living with rare kidney disease IgAN in the UK will soon be able to access a new oral treatment from CSL Vifor.

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GSK claims first approval for Nucala in COPD

GSK gets FDA approval for Nucala in COPD, setting up a marketing tussle with Sanofi/Regeneron's Dupixent.

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

Autolus closes on EU okay for leukaemia cell therapy

NICE relents and backs drug for IgAN from CSL Vifor

GSK claims first approval for Nucala in COPD

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