FDA

News

The FDA and EMA have come up with guiding principles that they say will underpin future guidance on the use of AI technologies in drug development.

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.

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.

News

FDA has turned down Sanofi's oral BTK inhibitor tolebrutinib for multiple sclerosis, despite suggesting earlier it would delay a decision until 2026.

R&D

Exploring the strategic shift toward reducing reliance on non-human primates (NHPs) and other animal species in R&D.