TAIPEI, Taiwan — OBI Pharma, a clinical stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody – drug conjugate (ADC) cancer therapy targeting TROP2. OBI plans...
Latest News
PRINCETON, N.J. – Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG). The FDA Fast Track is a process designed to facilitate the development...
Philadelphia, PA – A first-line therapy for obsessive-compulsive disorder (OCD) reshapes connectivity of the brain, according to a new study in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, published by Elsevier. OCD is an anxiety disorder characterized by repetitive thoughts and behaviors that can be disruptive and even disabling. The first-line...
REDWOOD CITY, Calif. – Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of...
LACHEN, Switzerland — New clinical data from Octapharma’s haematology portfolio will be presented during the scientific program at the 65th American Society of Hematology (ASH) Meeting and Exposition, which is being held on December 9–12, 2023, in San Diego, California. New data from the prospective clinical trial using wilate® for...
PARAMUS, N.J. — Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children 6 years...
MALVERN, Pa. — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data Safety and Monitoring Board (DSMB) for the OCU410ST clinical trial recently convened and approved to proceed dosing with the medium dose of...
BEDFORD, Mass. — Ocular Therapeutix Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal...
The Ogun State government has purchased a large quantity of drugs to fight schistosomiasis – a water borne disease caused by worms – which is prevalent in parts of the state, the state commissioner for health, Abiodun Oduwole has said. Mrs. Oduwole said this on Tuesday, during a meeting with...
COLUMBUS, Ohio — An Ohio mom says it took her months to say out loud that her son had a rare disease. “As soon as I Googled it, I knew what we were facing,” said Kelly Maynard. “That kicked off the worst six months of my life.” Her son, Jackson,...