With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
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.
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