FDA

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.

News

The next two discretionary priority vouchers to be awarded by the FDA are reported to be heading for two MSD drug candidates.

R&D

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

News

FDA approves its first 'national priority' drug – a version of the widely used antibiotic Augmentin XR – in double-quick time.