Ocugen, Inc. Receives Positive Scientific Advice From the EMA for Ocu410ST Gene Therapy for Stargardt Disease
Ocugen’s ongoing Phase 2/3 GARDian3 trial for Stargardt disease has received a positive opinion from the EMA’s Committee for...
Cognition Therapeutics and FDA Align on Zervimesine Trial for Alzheimer’s
Cognition Therapeutics received positive feedback from the FDA regarding its Phase 3 trial design for zervimesine (CT1812) in mild-to-moderate...
Aligos Doses First Subject in Phase 2b HBV Study
Aligos Therapeutics has initiated its Phase 2 B-SUPREME trial of ALG-000184, an oral capsid assembly modulator (CAM-E), in patients...
BioVie Unveils Phase 2 Trial Design for Long COVID Neurological Symptoms Treatment
BioVie Inc. is leveraging its experience in neuroinflammation to target the Long COVID market with bezisterim, an oral anti-inflammatory...
Celz-201-DDT Gets FDA Fast Track for Chronic Lower Back Pain
Creative Medical Technology Holdings (CELZ) has received FDA Fast Track designation for CELZ-201-DDT, its allogeneic perinatal cell therapy for...
FDA Approves Tiziana’s Phase 2 Trial for Multiple System Atrophy
Tiziana Life SciencesLife Sciences has received FDA clearance for a Phase 2a trial of intranasal foralumab in patients with...
io Bio Cylembio® Phase 3 Trial Shows Clinical Improvement, Narrowly Misses Significance
IO Biotech’s Phase 3 trial of Cylembio plus pembrolizumab in advanced melanoma narrowly missed statistical significance on its primary...
Forx Therapeutics Launches First-in-Human Trial of Novel Anti-Cancer Drug Forx-428
FoRx Therapeutics has dosed the first patient in a Phase 1 trial of FORX-428, an oral PARG inhibitor, in...
FDA Accepts Arvinas’s New Drug Application for Advanced Breast Cancer Treatment
The FDA accepted Arvinas and Pfizer’s New Drug Application (NDA) for vepdegestrant, an oral PROTAC estrogen receptor degrader, for...
Dogwood Therapeutics Enrolls First 50 Patients in Halneuron® Phase 2b Trial
Dogwood Therapeutics announced enrollment of the first 50 patients in its Phase 2b trial of Halneuron for chemotherapy-induced neuropathic...