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 ...
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 ...
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 ...
SAB Biotherapeutics’ SAB-176 Granted Breakthrough Therapy Designation by FDA for High-Risk Patients with Type A and B Influenza
SAB Biotherapeutics receives the FDA's Breakthrough Therapy Designation for SAB-176, an investigational therapeutic for post-exposure prophylaxis of Type A and Type B influenza illness in high-risk pa ...
Regenxbio’s RGX-202 Gene Therapy for Duchenne Muscular Dystrophy Receives Fast Track Designation from FDA
Regenxbio Inc. has received a fast track designation from the FDA for its innovative gene therapy, RGX-202, aimed at treating Duchenne muscular dystrophy. This therapy has been designed to deliver and ...
Sumitomo Pharma’s TP-1287 granted FDA Orphan Drug and Rare Pediatric Disease Designations for Ewing sarcoma
Sumitomo Pharma Oncology, Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for TP-1287, an oral CDK9 inhibitor that is being investigated for the treatment of ...
Verismo Therapeutics Receives Fast Track Designation from FDA for SynKIR-110, a Novel CAR T Therapy for Mesothelioma Treatment
Verismo Therapeutics, a clinical-stage company specializing in CAR T technology, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug, SynKIR-11 ...
Abbisko Cayman’s ABSK012 Granted FDA Orphan Drug Designation for Soft Tissue Sarcoma Treatment
Abbisko Therapeutics, a subsidiary of Abbisko Cayman, has been awarded an orphan drug designation by the US Food and Drug Administration (FDA) for ABSK012, an FGFR4 mutant inhibitor that treats soft t ...
Caribou Biosciences’ CB-011 Granted Fast Track Designation by FDA for Relapsed or Refractory Multiple Myeloma
Caribou Biosciences Ltd., a top-notch clinical-stage biopharmaceutical company specializing in CRISPR genome-editing, has recently received Fast Track designation from the U.S. Food and Drug Administr ...