regulatory approval

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Otsuka joins IgAN market with Voyxact approval in US

Otsuka has claimed FDA approval for its IgAN therapy Voyxact, joining an increasingly crowded market and beating rival Vera Therapeutics to the punch.

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Boy in wheelchair, only lower half of his body visible

Novartis' SMA gene therapy cleared for wider use in US

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 takes on Boehringer with FDA nod for lung cancer drug

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 gets EU approval for menopause drug Lynkuet

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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Representation on cellular level of lymphoma

Approvals extend use of Roche, AbbVie drugs in lymphoma

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 Oncology and Kyowa Kirin logos with Komzifti pill bottle

Kura scores FDA okay for rival to Syndax's leukaemia drug

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

Otsuka joins IgAN market with Voyxact approval in US

Novartis' SMA gene therapy cleared for wider use in US

Bayer takes on Boehringer with FDA nod for lung cancer drug

Bayer gets EU approval for menopause drug Lynkuet

Approvals extend use of Roche, AbbVie drugs in lymphoma

Kura scores FDA okay for rival to Syndax's leukaemia drug

Agios mulls early FDA filing for sickle cell therapy

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regulatory approval

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