FDA Grants Breakthrough Therapy Designation to Mirum’s Volixibat for Cholestatic Pruritus in PBC
Mirum Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough therapy designation to their drug, volixibat, as a potential treatment for cholestat ...
FDA Grants Fast Track Designation to MorphoSys AG’s Promising Endometrial Cancer Treatment
MorphoSys AG today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for tulmimetostat, an innovative dual inhibitor targeting EZH2 and EZH1. This breakthro ...
CyGenica Receives Orphan Drug Designation for Glioblastoma Multiforme (GBM) Treatment
CyGenica Limited, a dynamic biotech startup, has achieved a significant milestone in the fight against Glioblastoma Multiforme (GBM), an aggressive form of brain cancer. Dr. Nusrat J M Sanghamitra, Co ...
Healx Secures FDA Orphan Drug Designation for AI-Discovered NF1 Treatment – HLX-1502 Unveiled!
Healx, a cutting-edge techbio company driven by AI innovation and patient-centricity, has achieved Orphan Drug Designation from the US Food and Drug Administration (FDA) for its groundbreaking AI-driv ...
INOVIO’s INO-3107 Granted FDA Breakthrough Therapy Designation for RRP Treatment
INOVIO Pharmaceuticals, a leading biotechnology company, has received the FDA's Breakthrough Therapy designation for INO-3107. This DNA medicine shows promise in treating Recurrent Respiratory Papillo ...
Avenge Bio’s AVB-001 Granted FDA Orphan Drug Designation for Mesothelioma Treatment
Avenge Bio, Inc., a leading biotech firm specializing in oncology, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AVB-001. This designation recognizes AVB-00 ...
XORTX Therapeutics Secures Orphan Drug Designation for Oxypurinol to Treat Autosomal Dominant Polycystic Kidney Disease
XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company that aims to create new therapies to treat progressive kidney disease, is excited to announce that they have received Orphan Drug ...
FDA Grants Fast Track Designation to Bayer’s Asundexian for Stroke Prevention in Atrial Fibrillation Patients
Bayer has officially announced that the U.S. FDA has awarded Fast Track Designation to their investigational drug known as asundexian (BAY2433334). This designation recognizes its potential use as a t ...
Madrigal Pharmaceuticals’ Resmetirom Receives FDA Breakthrough Therapy Designation for NASH Treatment with Liver Fibrosis
Madrigal Pharmaceuticals, Inc. has received U.S. Food and Drug Administration (FDA's) Breakthrough therapy designation for resmetirom in the treatment of NASH patients with liver fibrosis. The company ...
Candel Therapeutics Receives U.S. FDA Fast Track Designation for CAN-2409 to Treat Stage III/IV NSCLC Patients
Candel Therapeutics receives FDA's fast track designation for CAN-2409, a viral immunotherapy developed to improve survival in combination with valacyclovir and pembrolizumab to treat stage III/IV non ...