United States Food and Drug Administration
FDA Approves Johnson & Johnson’s New Multiple Myeloma Therapy
FDA approval, Johnson & Johnson, multiple myeloma, CAR-T cell therapy, bispecific antibody, TALVEY, CARVYKTI, DARALEXASPRO
FDA Decision on Vertex’s Non-Opioid Analgesic Suzetrigine Due Early Next Year
FDA, Vertex, Suzetrigine, Non-Opioid Analgesic, Acute Pain, PDUFA, Priority Review
FDA Criticizes Brittany Mahomes’ Paid Instagram Post for Kaléo’s Auvi-Q
FDA, Brittany Mahomes, Kaléo, Auvi-Q, misleading advertisement, social media regulation, pharmaceutical marketing
FDA Approves New Oral Alzheimer’s Therapy, Expands Label for Grifols SCIg Therapy
FDA, Alzheimer’s disease, Grifols, XEMBIFY, immunoglobulin, subcutaneous, immunodeficiency, plasma-derived therapeutics
FDA Places Clinical Hold on vTv Therapeutics’ Diabetes Drug Program
vTv Therapeutics, diabetes drug, clinical hold, FDA, cadisegliatin, type 1 diabetes
FDA Halts vTv Therapeutics’ Type-1 Diabetes Clinical Trial Due to Chromatographic Signal
vTv Therapeutics, FDA, clinical trial, type-1 diabetes, cadisegliatin, chromatographic signal, patient safety, glucokinase activator
FDA Raises Concerns Over Potential Overtreatment with AstraZeneca’s Imfinzi for NSCLC
AstraZeneca, Imfinzi, NSCLC, FDA, Overtreatment, Adcomm, Perioperative Treatment, Immune Checkpoint Inhibitors, Neoadjuvant Chemotherapy, Adjuvant Monotherapy
FDA Advisers Call for Revamp of Perioperative Lung Cancer Trials Due to Frustration with AstraZeneca’s Imfinzi Design
FDA, Imfinzi, AstraZeneca, perioperative lung cancer trials, revamp, design issues
Sun Pharma Secures FDA Approval for Leqselvi, a JAK Inhibitor for Severe Alopecia Areata
Sun Pharma, Leqselvi, FDA Approval, Alopecia Areata, JAK Inhibitor, Pfizer, Lilly, Immunology, Dermatology
EU Panel Recommends Wegovy for Preventing Cardiac Events, Following FDA Lead
Wegovy, EU panel, FDA, cardiac events, weight loss, Novo Nordisk