Pharvaris Announces Orphan Designation Granted to Deucrictibant by the European Commission
The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to deucrictibant for the treatment of bradykinin-mediated angioedema in March 2022.
Pharvaris says EC grants orphan designation to deucrictibant
Pharvaris (PHVS) announced that the European Commission has granted orphan designation to its investigational drug, deucrictibant, for the ...
Exousia Pro Issues and Update on its FDA Orphan Drug Status
ORLANDO, FL / ACCESS Newswire / April 1, 2025 / MARIJUANA INC. (OTC PINK:MAJI), dba Exousia Pro, Inc., a clinical-stage biotech company using exosomes in the treatment of cancer and other maladies, is ...
Zacks Investment Research on MSN6h
SNY Gets FDA Nod for First Ever Hemophilia Drug in the United States
Sanofi SNY and partner, Alnylam Pharmaceuticals ALNY, announced that the FDA has approved Qfitlia (fitusiran) as the first ...
Targeted Oncology13d
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 ...
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 ...
JD Supra4d
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 ...
Morningstar13d
Rhythm Pharmaceuticals Announces Orphan Drug Designation Granted to Setmelanotide for Treatment of Hypothalamic Obesity in Japan
“Orphan drug designation points to the need for therapeutic options for people living with acquired hypothalamic obesity,” said Yann Mazabraud, Executive Vice President, Head of International ...
BioWorld1d
Pep-Therapy advancing orphan drug PEP-010 in pancreatic cancer
French biotech Pep-Therapy SAS is in the midst of raising a €20 million (US$21.62 million) round and, at the same time, prospecting for potential partners after winning FDA orphan drug designation for ...
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 ...
Morningstar13d
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer
has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. According to the U.S. FDA, the drug or ...