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 ...
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 ...
FDA Approves Neuren Pharmaceutical’s Phase II Trial of NNZ-2591 for Prader-Willi Syndrome
The FDA has approved Neuren Pharmaceuticals' Phase 2 clinical trial for its NNZ-2591 drug for children with Prader-Willi syndrome, a neurological disorder with no approved treatment options. The trial ...
DualityBio’s DB-1303 Granted Fast-Track Status by FDA for Advanced Endometrial Cancer Treatment
Duality Biologics has announced that the FDA has granted Fast Track Designation to DB-1303, a novel antibody-drug conjugate, for the treatment of advanced, recurrent or metastatic endometrial carcinom ...
FDA Approves TUKYSA® for Metastatic HER2-Positive Colorectal Cancer
Seagen Inc. announced FDA accelerated approval of TUKYSA for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer. It's the first FDA-approved treatment for HER2-positive metastat ...