regulatory approval

News

New approvals in the EU for Astellas' Padcev and Gilead's Trodelvy break new ground in the treatment of bladder and triple-negative breast cancer.

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CARSgen Therapeutics has claimed approval in China for gastric cancer therapy satri-cel, the first CAR-T to be cleared for a solid tumour.

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MSD has claimed new territory for pneumococcal vaccines after getting FDA approval for use of Capvaxive in vulnerable children aged two to 17.

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The first generic of Roche's drug for influenza, Xofluza, has been approved by the FDA and should be available in time for this year's flu season.

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Sanofi's on-body injector version of multiple myeloma therapy Sarclisa has been cleared in the UK, which will be the first market for the product.

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GSK has helped top up the antibiotic armamentarium in the US, after securing the first FDA approval for an oral carbapenem, Utebzi.