regulatory

News

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

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

News

New data from the UK medicines regulator has shown an increase in clinical trial activity in the country, after years of decline.

News

FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.

News

Vanda will continue to push for approval of Hetlioz for jet lag, despite the FDA saying its trial designs were not satisfactory.

Market Access

At ISPOR EU 2025, a cross-stakeholder panel addressed how Joint Clinical Assessment under the EU HTA Regulation is reshaping evidence strategies.