regulatory

News

As the celebrations for the end of 2025 gathered pace, the FDA delivered a year-end blow to Corcept by turning down its new Cushing's drug.

Digital

Digital systems are steadily replacing legacy software and automation tools roll out at speed to cut back the time clinicians spend on manual tasks.

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

While support for reducing animal use has never been stronger, the path to broad adoption is steep and complex.

News

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

News

The FDA has awarded its latest national priority voucher to Johnson & Johnson for a combination regimen based on Tecvayli for multiple myeloma.