United States Food and Drug Administration
FDA Rejects Atara’s Ebvallo Due to Manufacturing Issues, Not Efficacy or Safety Concerns
Atara Therapeutics, Ebvallo, FDA rejection, manufacturing issues, post-transplant lymphoproliferative disease (PTLD), Epstein-Barr virus (EBV), T-cell immunotherapy, Pierre Fabre Laboratories.
FDA Approves Lilly’s Omvoh for Crohn’s Disease, Expanding Treatment Options
Omvoh, FDA approval, Crohn’s disease, inflammatory bowel disease, mirikizumab-mrkz, Eli Lilly
OS Therapies Seeks Expedited FDA Approval Following Successful Mid-Stage Osteosarcoma Trial
OS Therapies, FDA approval, osteosarcoma, OST-HER2, mid-stage trial, expedited approval
Umoja Biopharma Advances In Situ CAR-T Therapy with FDA Clearance and $100M Series C Funding
Umoja Biopharma, CAR-T therapy, in situ, UB-VV111, FDA clearance, hematologic malignancies, Series C funding
2024 FDA Approvals: Breakthroughs in Cancer and Rare Diseases
FDA approvals, 2024, cancer treatments, rare diseases, novel drugs
FDA Sets Efficacy Threshold for Obesity Therapies Amid Market Expansion
FDA, obesity therapies, weight-loss treatments, efficacy standards, obesity market trends
FDA Mandates Guillain-Barré Syndrome Warning for Pfizer and GSK RSV Vaccines
RSV vaccines, Guillain-Barré syndrome, FDA warning, Pfizer, GSK, Abrysvo, Arexvy
FDA Updates Label for Agios’ PYRUKYND with New Liver Injury Warning
Agios Pharmaceuticals, PYRUKYND, mitapivat, liver injury warning, FDA label update, thalassemia treatment
FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025
FDA, AI, drug approval, guidance, regulatory decision-making, medical devices, artificial intelligence, drug development
FDA Advisory Panels: Activity Levels Normalize After 2023 Surge
FDA advisory panels, adcomms, regulatory changes, advisory committee meetings