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 ...
Moderna’s mRNA-1345 Receives Breakthrough Designation from FDA for Respiratory Syncytial Virus (RSV) Prevention
Moderna, a biotechnology company pioneering mRNA therapeutics and vaccines, announced that mRNA-1345, its investigational mRNA vaccine for respiratory syncytial virus (RSV), has received Breakthrough ...
Nanoscope Therapeutics’ MCO-010 Receives Fast Track Designation from FDA for Stargardt Disease Treatment
Nanoscope Therapeutics, a clinical-stage biotech company specializing in gene therapies for retinal disorders, announced that the US FDA has granted Fast Track Designation to MCO-010. an ambient-light ...
Abbisko Therapeutics’ Pimicotinib (ABSK021) Receives Breakthrough Therapy Designation from FDA for Treatment of Tenosynovial Giant Cell Tumor
Abbisko Therapeutics today announced that its CSF-1R inhibitor Pimicotinib（ABSK021）has been granted the breakthrough therapy designation from FDA for the treatment of tenosynovial giant cell tumor (TG ...
FDA Grants Fast-Track Designation to Tamibarotene for Higher-Risk Myelodysplastic Syndrome Treatment
Syros Pharmaceuticals, Inc., a biopharmaceutical company focused on improving treatment for hematologic malignancies patients through innovative standards of care, announces United States FDA has gran ...
Cidara Therapeutics and Melinta Therapeutics Announce FDA Approval for Rezafungin for Candidemia and Invasive Candidiasis Treatment
Cidara Therapeutics and Melinta Therapeutics announced that the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration (FDA) authorised rezafungin to treat candidemia and invasi ...
Poxel SA Receives Orphan Drug Designation from the European Commission for PXL770 and PXL065 for Treatment of Adrenoleukodystrophy
POXEL SA, a biotech company developing treatments for serious diseases, announces the European Commission grant of orphan drug designation for PXL770 and PXL065 for Adrenoleukodystrophy treatment. The ...
Verastem Oncology Boosts Ovarian Cancer Treatment with Positive Phase 2 RAMP-201 Trial Results
Verastem Oncology, a biopharmaceutical company developing cancer treatments, today reports positive interim data for avutometinib (VS-6766) from Part A of the ongoing RAMP 201 Phase 2 study evaluating ...
IVERIC bio’s Avacincaptad Pegol Receives Breakthrough Therapy Status from FDA for Geographic Atrophy Treatment
IVERIC bio, Inc. announces U.S. FDA Breakthrough Therapy designation for avacincaptad pegol (Zimura®), a novel investigational complement C5 inhibitor for treating Geographic atrophy (GA) secondary to ...