Biotechnology News

U.S. FDA (Office of Orphan Products Development) grants Orphan Drug Designation for Sovateltide, a potential first-in-class therapy that could transform the treatment of Neonatal Hypoxic-Ischemic...

Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment...

Appointments strengthen rare-disease commercialization planning and strategic partnering capabilities as Ebstrocel™ advances toward potential commercialization BOCA RATON, Fla., Sept. 14, 2026 ...

CRB-913 demonstrated statistically significant and clinically meaningful mean weight loss of 5% at 60 mg after 12 weeks with no plateau observedCRB-913 was generally well tolerated with psychiatric...

Asimov delivered a high performance cell line for Sidewinder's bispecific antibody, achieving titers of over 10 g/L in a platform fed-batch process.

CAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class,...

LEAWOOD, Kan., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Etienna Bio, Inc. today announced that it completed an INTERACT meeting with the U.S. Food and Drug Administration’s Center for Biologics Evaluation...

Gotistobart continues to show potential as chemotherapy-free monotherapy to reignite anti-tumor immunity in previously treated patients with squamous non-small cell lung cancer, where median survival...

Gotistobart zeigte weiterhin Potenzial als chemotherapiefreie Monotherapie zur Reaktivierung der Anti-Tumor-Immunität in bereits vorbehandelten Patientinnen und Patienten mit Plattenepithelkarzinom...

By improving demand visibility, the collaboration will reduce costs and supply shortages, and ensure that more patients can access life-saving biologics.