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 ...
FDA Grants Orphan Drug Status to Zydus Lifesciences’ ZYIL1 for Treating Cryopyrin-Associated Periodic Syndrome
Zydus Lifesciences has announced that its drug, ZYIL1, has received orphan drug designation (ODD) from the United States Food and Drug Administration (US FDA) for the treatment of Cryopyrin Associated ...
Prestige Biopharma’s PBP1510 Granted Fast Track Designation by FDA for Advanced Pancreatic Cancer Treatment
Prestige Biopharma, a leading biopharmaceutical company, has secured Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug, PBP1510 (International Non-proprie ...
Ellipses Pharma’s EP0042 Granted Orphan Drug Designation by FDA for AML Treatment
Ellipses Pharma obtains Orphan Drug Designation (ODD) from the FDA for EP0042, a dual FLT-3 and Aurora kinase inhibitor, as a treatment for acute myeloid leukaemia (AML). This designation is granted t ...
IASO Bio’s CT103A Receives RMAT & Fast Track Designation from FDA for Treating Relapsed/Refractory Multiple Myeloma
IASO Biotherapeutics, a clinical-stage biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMA ...
FDA Grants Orphan-Drug Exclusivity to Recorlev® for Endogenous Cushing’s Syndrome Treatment
Xeris Pharmaceuticals has revealed that the FDA has awarded orphan-drug exclusivity for its drug Recorlev® (levoketoconazole) for treating adult patients with endogenous Cushing's syndrome for whom su ...
FDA Grants Orphan Drug Status to Beactica’s BEA-17 for Glioblastoma Treatment
Beactica Therapeutics, a Swedish precision oncology company, announced today that the U.S. FDA has designated BEA-17 as an orphan drug for the treatment of glioblastoma (GBM). BEA-17 is a first-of-its ...
FDA Grants Fast Track Designation for Reneo Pharma’s Mavodelpar (REN001) for LCHAD Deficiency Treatment
Reneo Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing and commercialising therapies for patients with rare genetic mitochondrial diseases granted Fast Track design ...
FLAG Therapeutics’ FLAG-003 Receives Rare Pediatric Disease Designation from FDA for Diffuse Intrinsic Pontine Glioma (DIPG) Treatment
FLAG Therapeutics announces FLAG-003 granted Rare Pediatric Disease designation by FDA. FLAG-003 is an investigational therapy for treating Diffuse Intrinsic Pontine Glioma (DIPG), a rare, aggressive ...