regulatory approval

News

Verona’s first-in-class COPD drug ‘could transform market’

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.

News

Akili lifted by FDA nod for adult ADHD digital therapeutic

Akili’s new era as a subsidiary of Virtual Therapeutics will start with FDA approval of its digital therapeutic for attention-deficit hyperactivity disorder (ADHD) in adults, a key part of

News

Alnylam chief executive Yvonne Greenstreet

Alnylam’s vutrisiran aces ATTR cardiomyopathy readout

Alnylam is riding high today after reporting its RNAi drug vutrisiran showed across-the-board efficacy in cardiomyopathy associated with transthyretin-mediated amyloidosis (ATTR), setting u

News

BMS gets FDA approval for Krazati in colorectal cancer

Bristol-Myers Squibb’s KRAS inhibitor Krazati has been approved for a second indication, colorectal cancer (CRC), which could inject some much-needed sales growth into the product.

News

FDA clears Argenx’ Vyvgart Hytrulo for rare disease CIDP

Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug t

News

Sarepta bags key expansion to DMD gene therapy label in US

Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD) will be an option for many more patients in the US after the FDA expanded the breadth of its approved labelling.

Verona’s first-in-class COPD drug ‘could transform market’

Akili lifted by FDA nod for adult ADHD digital therapeutic

Alnylam’s vutrisiran aces ATTR cardiomyopathy readout

BMS gets FDA approval for Krazati in colorectal cancer

FDA clears Argenx’ Vyvgart Hytrulo for rare disease CIDP

Sarepta bags key expansion to DMD gene therapy label in US

Are Makary's priority review vouchers about to be canned?

Securing your ROI: Turning post-acquisition integration into...

regulatory approval

Editor's Picks