United States Food and Drug Administration
New York Attorney General Demands Enhanced Safety Labeling for Pediatric Use of Singulair
Singulair, United States Food and Drug Administration, Pediatric brand name, Child, Lawyer (occupation)
Minerva Entangles in Web of FDA Rejection Again Over Schizophrenia Drug Roluperidone
United States Food and Drug Administration, MFSD1 gene, Schizophrenia
Venatorx Confident in Quick Resolution of Manufacturing Concerns for Cefepime-Taniborbactum Antibiotic Despite FDA Setback
United States Food and Drug Administration, Venatorx, CID, 2024-02-23, cefepime-taniborbactam, Manufacture
FDA Approves Xolair (Omalizumab) for Reducing Severe Outcomes from Multiple Food Allergies
Xolair, United States Food and Drug Administration, omalizumab, Hypersensitivity, Food, Reduced, Severe (severity modifier)
FDA Approves Amtagvi as the First One-time Cell Therapy for Solid Tumors: A Groundbreaking TIL Immunotherapy for Advanced Melanoma
Amtagvi, Solid Neoplasm, United States Food and Drug Administration, Lymphocytes, Tumor-Infiltrating
FDA Awaits Final Decision on Madrigal’s Resmetirom for NASH Treatment with Priority Review and NDA Acceptance Set for March 14, 2024
Nonalcoholic Steatohepatitis, resmetirom, United States Food and Drug Administration, New Drug Application, Priority Review, Fibrosis, Liver, Liver, Madrigal’s, March 14, 2024
FDA rejects Defender’s motion sickness treatment
United States Food and Drug Administration, Safety, Effectiveness
Fake versions of Novo Nordisk’s Ozempic linked to 3 dangerous hypoglycemia cases in US: Reuters
Hypoglycemia, Case (situation), Ultrasonography, Nordisk’s, United States Food and Drug Administration
Sarepta shares PhII data for next-gen exon skipping drug, but regulatory pathway is unclear
Regulatory Pathway, Sarepta, next-generation exon-skipping drug, United States Food and Drug Administration, Approved, Muscular Dystrophy, Duchenne, gene therapy, Sarepta’s gene therapy
Lilly’s Donanemab Poised for FDA Decision amid Embraced Alzheimer’s Disease Competition
Alzheimer’s Disease, Donanemab, United States Food and Drug Administration, Lilly’s