regulatory approval

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Can FDA approval of Jazz Pharma's Zepzelca in a combination regimen for extensive-stage small cell lung cancer return sales of the drug to growth?

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The FDA has cleared another generic of the abortion pill mifepristone, as it carries out a review of the drug that has been criticised as spurious.

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Novartis has claimed a first-in-class approval in the US for its oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria.

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Lilly's Inluriyo is the second oral SERD to reach the US market for ESR1-mutated breast cancer, setting up a market tussle with Menarini's Orserdu.

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Biolinq gets an FDA green light for its autonomous, needle-free continuous glucose monitor, plus a roundup of other medtech developments.

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After a long haul, Stealth BioTherapeutics has finally claimed FDA approval for Forzinity, the first treatment for ultra-rare disease Barth syndrome.