Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Bristol Myers Squibb, Cour, Cyprium, Ensem, Evofem, Fortress, Novartis, Pharma 1, Pharming, Sentynl, Taho.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
Takeda Pharmaceutical Co. Ltd. is exiting all work in cell therapies and will seek an external partner to advance the company’s research and clinic-ready cell therapy programs, the company said, noting that it is not currently running any clinical trials using cell therapy technology.
Synendos Therapeutics AG has delivered initial clinical data demonstrating the potential of its lead compound to selectively modulate the endocannabinoid system in the brain and to relieve anxiety symptoms without triggering a psychoactive response.
The BioWorld Cancer Index closed the third quarter (Q3) of 2025 with a 24.15% gain, marking its highest level of the year. The climb reversed earlier declines, including a 12.81% drop at the end of Q1, and half-year performance of 2.21%. Broader markets showed a similar rebound, with the Nasdaq Biotechnology Index up 13.21% and the Dow Jones Industrial Average rising 9.06%, both finishing Q3 at their highest points of 2025.
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