regulatory

News

FDA starts review of Summit's VEGFxPD-1 bispecific

Summit moves ahead in the race to bring a VEGFxPD-(L)1 drug to market, after the FDA started a review of ivonescimab in lung cancer.

News

ADHD in wooden letters surrounded by white pills

Otsuka preps for July decision on centanafadine for ADHD

The FDA has started a priority review of Otsuka's triple-acting drug for ADHD, setting up a decision on the first-in-class drug in July.

Digital

Digital mental health technologies and the changing face of ...

Digital Mental Health Technologies, from apps and online platforms to AI-powered tools, are fast being seen as essential to help close treatment gaps.

News

ImmunityBio rises as route opens to broader Anktiva label

Shares in ImmunityBio shot up after it agreed a path with the FDA that should allow it to refile for wider use of its bladder cancer drug Anktiva.

News

FDA seeks changes to GLP-1, flu shot labels

The FDA has asked manufacturers of GLP-1 drugs used for weight loss to remove warnings of suicidal thinking, but added warnings to flu shots.

R&D

Magnifying glass over years including 2026

Looking ahead to 2026 in biopharma

A look forward to trends to come in 2026, including AI-driven drug development, advanced modalities, and cardiometabolic disease therapies.

FDA starts review of Summit's VEGFxPD-1 bispecific

Otsuka preps for July decision on centanafadine for ADHD

Digital mental health technologies and the changing face of ...

ImmunityBio rises as route opens to broader Anktiva label

FDA seeks changes to GLP-1, flu shot labels

Looking ahead to 2026 in biopharma

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

How to meet your physicians where they are online

regulatory

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