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AstraZeneca has claimed another key FDA approval for Imfinzi in bladder cancer, as an add-on to BCG therapy for early non-muscle invasive disease.

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The FDA has started a priority review of Sanofi's brain-acting Gaucher disease therapy venglustat, with an action date of 25th November.

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AbbVie's Decnupaz approval will give patients with rare blood cancer BPDCN an alternative to Stemline's Elzonris with a simpler dosing regimen.

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After an advisory committee setback, AstraZeneca has a chance to make the case for its oral SERD camizestrant for breast cancer.

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At its second attempt, Gilead has won FDA approval for chronic hepatitis D virus drug Hepcludex, four years after it was cleared in the EU.

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The CHMP recommended eight new medicines and 13 line extensions at its May meeting, including Novo Nordisk's oral weight loss therapy.