Spero Therapeutics Announces FDA Acceptance and Priority Review of Tebipenem HBr New Drug Application for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
Spero Therapeutics, Inc. today announced that the U.S. FDA has granted Priority Review designation and confirmed acceptance for substantive review of the New Drug Application (NDA) seeking approval fo ...
FDA grants rare pediatric disease designation to IMX-110 for Rhabdomyosarcoma (RMS) treatment
Immix Biopharma, Inc., a biopharmaceutical company that pioneered Tissue-Specific Therapeutics (TSTx)TM for oncology and immuno-dysregulated diseases, announced today that the U.S. Food and Drug Admin ...
U.S. FDA Grants Orphan Drug Exclusivity for Xywav® Oral Solution for Idiopathic hypersomnia (IH) in Adults
The United States Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) to Jazz Pharmaceuticals plc's Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution f ...
FDA Gives Voxelotor Accelerated Approval for Kids with Sickle cell disease (SCD)
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of a supplemental New Drug Application (sNDA) for Oxbryta® (voxelotor) tablets for the treatment of Sickle cell disease (SC ...
NeurOp Receives FDA Orphan Drug Designation for NP10679 for Subarachnoid Hemorrhage Treatment
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to NeurOp, Inc.'s investigational candidate NP10679 to treat Subarachnoid hemorrhage (SAH). NeurOp is working on a subun ...
FDA grants AOC 1001 Fast Track Designation to treat Myotonic Dystrophy Type 1 (DM1).
AOC 1001, an investigational treatment for Myotonic Dystrophy Type 1 (DM1), a late-developing muscle disorder, has received fast track designation from the U.S. Food and Drug Administration (FDA). The ...
FDA Grants Rare Pediatric Disease Designation to 177Lu-omburtamab-DTPA for Medulloblastoma
Y-mAbs Therapeutics, Inc., a commercial-stage biopharmaceutical company concentrated on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer; ...
U.S. FDA has granted NuCana Fast Track Designation for Acelarin® for the Treatment of Biliary Tract Cancer.
Acelarin (NUC-1031), which is currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer, has been granted Fast Track desig ...
FDA Approval for Zanubrutinib in Waldenstrom macroglobulinemia (WM)
According to BeiGene, the drug's manufacturer, the U.S. FDA has approved zanubrutinib (Brukinsa) capsules to treat adult patients with Waldenstrom macroglobulinemia (WM), a rare non-Hodgkin lymphoma. ...
Moderna Announces First Patient Dose in mRNA-3705 Phase 1/2 Study for Methylmalonic Acidemia (MMA).
Moderna, Inc., a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the first patient had been enrolled in the Phase 1/2 study evaluat ...