regulatory approval

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Alzheimer's drug Leqembi to launch at discount to Aduhelm

Eisai and Biogen's Alzheimer's therapy Leqembi will be priced at $26,500 per year – a little less than misfired predecessor Aduhelm – after getting conditional authorisation for the drug fr

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FDA approves twice-yearly resistant HIV therapy from Gilead

Gilead Sciences has claimed FDA

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Roche claims US approval for lymphoma bispecific Lunsumio

The FDA has given a green light to Roche's CD20xCD3 bispecific antibody Lunsumio as a treatment for relapsed or refractory follicular lymphoma, following the lead of the European Commission

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AbbVie claims key approval for Vraylar in depression

AbbVie has secured its fourth FDA approval for Vraylar, adding adjunctive therapy of major depressive disorder (MDD) to a list that includes schizophrenia and manic and depressive episodes

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Mirati challenges Amgen with FDA okay for KRAS drug

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati's adagrasib as Krazati for a form of lung cancer.

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SMC gives Bayer's CKD therapy Kerendia the green light in Sc...

In another win for Bayer, the Scottish Medicines Consortium (SMC) has accepted the company’s chronic kidney disease (CKD) drug, Kerendia (finerenone), for the treatment of adults with CKD a

Alzheimer's drug Leqembi to launch at discount to Aduhelm

FDA approves twice-yearly resistant HIV therapy from Gilead

Roche claims US approval for lymphoma bispecific Lunsumio

AbbVie claims key approval for Vraylar in depression

Mirati challenges Amgen with FDA okay for KRAS drug

SMC gives Bayer's CKD therapy Kerendia the green light in Sc...

Delivering the right behavioural ingredients for the moment,...

How to meet your physicians where they are online

regulatory approval

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