regulatory affairs

'Clinical intuition' led FDA advisors to back Zevra's rare disease med

Zevra’s rare disease drug seems to be on the path to approval after gaining the backing of an FDA advisory committee, although the experts were split.

Annalee Armstrong Aug 5, 2024 10:35am

Takeda takes $140M loss on failed epilepsy drug, touts FDA run

Jul 31, 2024 9:14am

Allarity warned of pending SEC charges over FDA meeting conduct

Jul 22, 2024 9:50am

Insmed's shares double as lung disease med powers past phase 3

May 28, 2024 10:32am

Larimar's Friedreich's ataxia program free at last from FDA hold

May 21, 2024 9:55am

US agencies outline new plan for biotech product regulation

May 9, 2024 4:00am