regulatory approval

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A new FDA approval means Novartis now has a gene therapy option for almost everyone with spinal muscular atrophy (SMA), regardless of their age.

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Bayer joins Boehringer with FDA approval for a second-line, oral therapy for HER2-positive lung cancer, setting up a marketing battle in the US.

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Bayer now has approval on both sides of the Atlantic for Lynkuet, with the EU backing it for symptoms caused by both menopause and breast cancer.

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Patients in the US and EU with follicular lymphoma have new treatment options, thanks to new approvals for CD20xCD3 bispecifics Lunsumio and Epkinly.

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Kura has claimed FDA approval for oral menin inhibitor Komzifti for acute myeloid leukaemia, setting up a battle with Syndax's rival Revuforj.

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Johnson & Johnson has clinched an FDA approval for Caplyta in depression, satisfying a major driver for its $14.6bn takeover of ICT this year.