Zenas Biopharma Inc.’s positive data from the phase III Indigo trial with obexelimab in immunoglobulin G4-related disease (IgG4-RD) set investigators to speculating about the bifunctional antibody’s odds in the marketplace, as the Waltham, Mass.-based firm plans a BLA submission the U.S. FDA in the second quarter of this year. Read More
With plans in place to launch global pivotal testing of GH-001, its inhaled version of psychedelic mebufotenin (5-MeO-DMT), in treatment-resistant depression in 2026, GH Research plc reported the lifting of a U.S. FDA clinical hold, enabling U.S. subject enrollment. The firm now will seek a meeting with the agency to discuss trial design. Read More
After raising $292 million in its Hong Kong IPO, AI discovery and development biotech, Insilico Medicine, signed an R&D collaboration with French pharma Servier SA valued at $888 million to discover and develop innovative oncology therapies by combining Insilico's AI-driven drug discovery platforms with Servier's global expertise in cancer drug development. Read More
Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases. Read More
After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation. Read More
With the stroke of a pen and no input from the CDC’s Advisory Committee for Immunization Practices, acting CDC Director Jim O’Neill cut the number of vaccines the agency routinely recommends for children to 11 on Jan. 5, down from 17 in 2024. Read More
Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis. Read More
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