Marvel to File for Orphan Drug Designation with The U.S. FDA for MB-204 as a Treatment for Rett Syndrome
Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF), and its wholly owned subsidiary, Marvel Biotechnology Inc.
Nurix Announces U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia
Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström MacroglobulinemiaFirst-in-class ...
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FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
The FDA has granted orphan drug designation to PEP-010 for pancreatic cancer, advancing its development as a potential novel ...
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Bexobrutideg Receives Orphan Drug Designation in Waldenström Macroglobulinemia
Bexobrutideg, a bioavailable agent, was granted orphan drug designation by the FDA for Waldenström macroglobulinemia, a type ...
Nurix Gets FDA Orphan Designation for Bexobrutideg in Waldenstrom Macroglobulinemia
Nurix on Monday said the FDA granted orphan-drug designation to bexobrutideg, also known as NX-5948, for the treatment of Waldenstrom macroglobulinemia, a slow growing type of non-Hodgkin's lymphoma ...
Korro Bio gets Orphan Drug Designation from FDA for its genetic disorder treatment
Korro Bio (NASDAQ:KRRO) said on Friday that it received U.S. FDA's orphan drug designation for investigational medicine ...
GRIN Therapeutics Receives FDA Orphan Drug Designation for Radiprodil for the Treatment of GRIN-Related Neurodevelopmental Disorder
GRIN Therapeutics, Inc., a leader in the development of therapies to treat serious neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug ...
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PSTV Stock Skyrockets on FDA's Orphan Drug Tag for Cancer Therapy
Shares of Plus Therapeutics, Inc. PSTV were up a whopping 311.4% on March 6 after the company announced that the FDA has ...
Korro Bio's KRRO-110 Gets FDA Orphan Drug Designation
Korro Bio disclosed that the Food and Drug Administration granted orphan drug designation to its potential genetic disorder drug KRRO-110. Shares rose 17.6% to $29 in premarket trading. The stock is ...
BioArctic receives Orphan Drug Designation for exidavnemab the US
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment ...
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FDA grants fast track designation to X-linked retinoschisis treatment
The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release ...
PEP-Therapy receives FDA Orphan Drug Designation for PEP-010 for treatment of Pancreatic Cancer
Therapy receives FDA Orphan Drug Designation for PEP-010for treatment of Pancreatic CancerParis (France), March 17, 2025 – ...