U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Bionet, Celcuity, Celltrion, Dewpoint, Grifols, Vasa.
Immunotherapy-focused biotech company LTZ Therapetics Inc. and GSK plc are partnering to develop up to four potential first-in-class myeloid cell engagers using LTZ’s immune-engager platform to target blood cancers and solid tumors.
Tempest Therapeutics Inc. entered definitive agreements approved by its board to acquire certain dual-targeting CAR T programs from Factor Bioscience Inc. and its affiliates in an all-stock transaction expected to close in early 2026.
The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
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