regulatory approval

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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

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AZ claims another Imjudo approval, in big first-line NSCLC m...

Just a couple of weeks after finally getting its first FDA approval for CTLA4 inhibitor Imjudo for advanced liver cancer, AstraZeneca has picked up another – and in a much larger patient po

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J&J nabs FDA okay for BCMA bispecific Tecvayli

Johnson & Johnson has secured another regulatory approval for its BCMAxCD3 bispecific antibody for multiple myeloma – Tecvayli – adding to the wide range of therapies available for the

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...

AZ claims another Imjudo approval, in big first-line NSCLC m...

J&J nabs FDA okay for BCMA bispecific Tecvayli

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

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