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NFlection Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare RASopathies, today announced that the Food and Drug Administration has. ....
FDA Grants Bionaut Labs Orphan Drug Designation to BNL-101 for the Treatment of Malignant Gliomas in Pediatric and Adult Patients prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
Syndax Announces Orphan Drug Designation Granted to Axatilimab for Treatment of Idiopathic Pulmonary Fibrosis News provided by Share this article Share this article WALTHAM, Mass., April 8, 2021 /PRNewswire/ Syndax Pharmaceuticals, Inc. ( Syndax, the Company or we ) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to axatilimab, its anti-CSF-1R monoclonal antibody, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). IPF is a serious, life-limiting orphan disease, and today s Orphan Drug Designation validates axatilimab s potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease, said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. Building on promising data demonstrating meaningful multiorgan ....
Ambrx gets orphan drug designation for gastric cancer treatment ARX788 pharmaceutical-business-review.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceutical-business-review.com Daily Mail and Mail on Sunday newspapers.
Share this article Share this article NEW YORK, March 11, 2021 /PRNewswire/ Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with malignant gliomas. The FDA s Office of Orphan Drug Products grants Orphan Drug Designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and market exclusivity for seven years upon FDA approval. ....