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Siegfried Opens API Facility in Germany Adding 100 m³ Reactor Capacity for Small-Molecule CDMOs
Siegfried adds 100 m³ reactor capacity at its German site, expanding European small-molecule API output for CDMO clients.
Simantini Singh Deo
Norwich Pharmaceuticals Gains FDA Approval for First Generic Baloxavir Marboxil Ahead of 2026–2027 Flu Season
Norwich Pharmaceuticals gains FDA approval for the first generic baloxavir marboxil, cleared ahead of the 2026–2027 influenza season.
Simantini Singh Deo
Kite Pharmaceuticals Gains FDA Approval Expanding TECARTUS Label Following REMS Elimination in 2025
FDA's June 2026 TECARTUS approval and 2025 REMS elimination reshape post-market obligations for Kite's CAR-T program.
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Novartis Gains FDA Approval for ITVISMA in SMA Patients Aged 2 and Older
Novartis gains FDA approval for ITVISMA in SMA patients aged 2 and older, expanding the label and raising GMP compliance considerations for ATMP manufacturers.
Simantini Singh Deo
