Targeted Oncology1h
FDA Grants Orphan Drug Designation to HLX22 for Gastric Cancer Treatment
The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal ...
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 ...
CURE2d
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 ...
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 ...
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 ...
Morningstar2d
BioArctic receives Orphan Drug Designation for exidavnemab the US
The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the treatment of diseases that affect fewer than 200,000 people in the United States.
CURE2d
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 ...
Targeted Oncology1d
Bexobrutideg Gains FDA Orphan Drug Status in Waldenström Macroglobulinemia
Bexobrutideg, a first-in-class Bruton’s tyrosine kinase degrader, has been granted orphan drug designation from the FDA in ...
Clinical Trials Arena on MSN1d
AstraZeneca’s $1bn hypoparathyroidism drug achieves success at Phase III
UK-based AstraZeneca’s acquired rare disease drug has met the primary endpoint in a Phase III trial in patients with chronic ...
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 – ...