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 ...
Renovion’s ARINA-1 Receives Fast Track Designation from FDA for Prevention of BOS Progression in Bilateral Lung Transplant Patients
Renovion, Inc. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ARINA-1, a medicine developed for the prevention of bronchiolitis obliterans syndrome (BOS) prog ...
FDA Grants Fast Track Designation to EpicentRx’s RRx-001 for Severe Oral Mucositis Prevention in Head & Neck Cancer Patients
EpicentRx, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to RRx-001, a novel compound with direct NLRP3 inhibitory and Nrf2 upregulatory effect ...
AnGes’ Lonafarnib Granted Orphan Drug Designation by Japanese Ministry of Health for HGPS Treatment
Anges Inc. announced that Lonafarnib (marketed in the US as Zokinvy), a medication designed to treat Hutchinson-Gilford Progeria Syndrome (HGPS) and Processing-Deficient Progeroid Laminopathy (PL), ha ...
Pharming Group’s Joenja® receives FDA approval for the treatment of rare APDS condition in Adults and Pediatric patients
Pharming Group N.V. has received FDA approval for Joenja® (leniolisib) to treat activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in patients aged 12 and above. Joenja® is a selective ...