regulatory approval

News

AstraZeneca is the first company to get FDA approval for an aldosterone synthase inhibitor for hypertension, ahead of rival Mineralys.

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BeOne gets the nod for BCL2 inhibitor Beqalzi in mantle cell lymphoma, while Taiho's Inqovi has acute myeloid leukaemia added to its label.

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Partner's Bizengri has been approved for a rare form of bile duct cancer, two days after being awarded a national priority review voucher.

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Arvinas and Pfizer's Veppanu is the first PROTAC – and third oral SERD for breast cancer – to be approved by the FDA.

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Axsome's Auvelity has become the first non-antipsychotic therapy for agitation in patients with Alzheimer's disease to be approved by the FDA.

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Patients in the EU with the ultra-rare disease WHIM syndrome now have their first approved treatment, Norgine's Xolremdi.