regulatory

News

FDA has delivered a setback to AstraZeneca by rebuffing its new formulation of lupus therapy Saphnelo, which was approved in Europe last year.

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The FDA has turned down Pharming's bid to broaden the label of Joenja for rare immunodeficiency disorder APDS so it can be used in younger patients.

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The FDA has started accepting requests to participate in its PreCheck pilot programme, promising rapid reviews of new manufacturing facilities.

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UCB gets an EU recommendation for the first therapy for thymidine kinase 2 deficiency (TK2d), plus other CHMP decisions.

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Concerns about efficacy data in the main trial behind the approvals of Amgen and CSL Vifor's Tavneos have triggered a review in the EU.

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Summit moves ahead in the race to bring a VEGFxPD-(L)1 drug to market, after the FDA started a review of ivonescimab in lung cancer.