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regulatory affairs
Biotech
'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