Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently ...
The FDA issued a third complete response letter for ONS-5010/Lytenava, requesting confirmatory efficacy evidence for wet AMD treatment. Lytenava is an ophthalmic bevacizumab formulation, potentially ...
Capricor Therapeutics is raising issues with the U.S. Food and Drug Administration's new policy of publishing rejection letters sent to drugmakers. The FDA in June began publishing older letters, ...
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
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