United States Food and Drug Administration
“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”
ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy
J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations
Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application
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