regulatory approval

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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

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uniQure, CSL claim first okay for haemophilia B gene therapy

uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy fo

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Provention finally gets FDA nod for type 1 diabetes drug tep...

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-m

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...

uniQure, CSL claim first okay for haemophilia B gene therapy

Provention finally gets FDA nod for type 1 diabetes drug tep...

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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