The FDA has granted orphan drug designation to PEP-010 for pancreatic cancer, advancing its development as a potential novel ...

Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal ...

Shares of Soleno Therapeutics SLNO have rallied 37% in the premarket hours today following the FDA approval of Vykat XR ...

Orphan Drug Designation follows positive Phase 1 data presented at the 12th International Workshop on Waldenström Macroglobulinemia First-in-class Bruton’s tyrosine kinase (BTK) degrader NX-5948 ...

ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA ...

Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma ...

Evaluate, the leading provider of market insights for the pharmaceutical industry, today released its 2025 Orphan Drug Report highlighting forecasts for the orphan drug market out to 2030. The 2025 ...

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...

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 ...

Rhythm Pharmaceuticals, Inc. has announced that it received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for setmelanotide, a treatment aimed at acquired ...

SHANGHAI, March 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22 ...