JD Supra6h
Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer
Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal ...
ReCode Therapeutics Receives U.S. FDA Orphan Drug Designation for RCT2100 for the Treatment of Cystic Fibrosis
ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA ...
CURE11d
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 ...
Zacks Investment Research on MSN1d
SLNO Stock Rallies on FDA Approval of Prader-Willi Syndrome Drug
Shares of Soleno Therapeutics SLNO have rallied 37% in the premarket hours today following the FDA approval of Vykat XR ...
FDA approves Sanofi’s hemophilia treatment Qfitlia
Investing.com -- The US Food and Drug Administration (FDA) has approved Sanofi (NASDAQ: SNY )’s treatment for hemophilia, Qfitlia (fitusiran), which can be administered as infrequently as once every ...
Tempest Reports Year End 2024 Financial Results and Provides Business Update
Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma ...
PharmiWeb10d
Evaluate Releases 2025 Orphan Drug Report
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 ...
Palatin's Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency
Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on ...