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...
treatment News
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. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the first patient has been dosed in its Phase 2/3 GARDian3 clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for all Stargardt disease...
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...
MALVERN, PA. — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis...
MALVERN, Pa. — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a...
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...
ZUG, Switzerland – Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs, today announces the advancement of Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the U.S. Food and Drug Administration...
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...
NEW YORK, NY – Olatec Therapeutics, Inc., a leader in the developing class of selective NLRP3 inhibitors, today announced that Cure Parkinson’s granted an award to initiate a Phase 2 clinical trial investigating the potential of oral dapansutrile to slow or stop the progression of Parkinson’s disease. Parkinson’s is a...