Hope Medicine Inc. Announces Positive Phase 2 Results for HMI-115 in Endometriosis Treatment
Hope Medicine Inc., a clinical-stage innovative biopharmaceutical company, announced positive results from an interim analysis of a global Phase 2 study, titled "A Randomized, Multicenter, Double-Blin ...
FDA Grants Orphan Drug Designation to Kind Pharmaceutical’s AND017 for Sickle Cell Disease
Kind Pharmaceutical, a clinical-stage biopharmaceutical company focused on developing innovative medicines to treat hematological diseases and cancers, announced that the U.S. Food and Drug Administra ...
FDA Grants Fast Track Designation to HiberCell’s HC-7366 for Acute Myeloid Leukemia Treatment
HiberCell, Inc., a clinical-stage biotechnology company focused on developing therapeutics to combat advanced cancer and cancer resistance, announced that the U.S. Food and Drug Administration (FDA) h ...
FDA Clears Autobahn’s IND for Phase 2 Trial of ABX-002 in Bipolar Depression
Autobahn Therapeutics, a biotech company focused on developing restorative treatments for neuropsychiatric and neuroimmunologic disorders, announced the clearance of an investigational new drug (IND) ...
FDA Approves AbbVie’s VYALEV for 24-Hour Treatment of Advanced Parkinson’s Disease
AbbVie announced that the U.S. FDA has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in ...
Sangamo Therapeutics Gains FDA Pathway to Accelerated Approval for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, Inc., a genomic medicine company, announced the outcome of a recent successful interaction with the U.S. Food and Drug Administration. This interaction has provided a clear regul ...
FDA Grants Orphan Drug Designation to Remedy Pharma’s CIRARA for Treatment of Acute Ischemic Stroke
Remedy Pharmaceuticals, a pioneer in stroke drug development, has announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Division (OOPD) has granted Orphan Drug Designati ...
EMA Grants Orphan Drug Designation to NIDO-361 for Kennedy’s Disease
Nido Biosciences, a biopharmaceutical company developing medicines to treat debilitating neurological diseases with precision, today announced that the European Medicines Agency has granted an Orphan ...
FDA Approves Astellas’ VYLOY for HER2-Negative Gastric and GEJ Adenocarcinoma
Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-containing chemot ...
Glaukos’ Epioxa Achieves Positive Phase 3 Results for Keratoconus Treatment
Glaukos Corporation announced that the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on) met its pre-specified primary efficacy endpoint. This next-generation corneal cross-linking iLink ...