United States Food and Drug Administration
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease Over Manufacturing Concerns
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Concerns
J&J, Legend’s Phase III Win Cements Carvykti as Earlier-Line Multiple Myeloma Treatment
Carvykti, Multiple Myeloma, Phase III, CARTITUDE-4, FDA Approval, BCMA-Targeted Therapy, Johnson & Johnson, Legend Biotech
FDA Approves Lilly’s Donanemab for Alzheimer’s Treatment Amid Manufacturing Concerns
FDA Approval, Donanemab, Alzheimer’s Disease, Eli Lilly, Manufacturing Issues, Amyloid-Targeting Drug
Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority
Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter
Merck and Daiichi Sankyo’s ADC Pact Hits Regulatory Setback in FDA Rejection
Merck, Daiichi Sankyo, Antibody-Drug Conjugate (ADC), Patritumab Deruxtecan, FDA Rejection, Regulatory Setback, HER3 Protein, Non-Small Cell Lung Cancer (NSCLC)
Lykos Faces Setback as ICER Concludes Insufficient Evidence for MDMA-Based PTSD Treatment
Lykos Therapeutics, MDMA, PTSD, ICER, Insufficient Evidence, Clinical Trials, FDA Approval
FDA Rejects Merck-Daiichi Sankyo’s Lung Cancer Drug, Approves New Treatments for COPD and Lymphoma
FDA, Merck, Daiichi Sankyo, NSCLC, COPD, Lymphoma, Patritumab Deruxtecan, Ensifentrine, Epkinly
FDA Rejects Merck-Daiichi’s HER3-Targeted ADC Due to Manufacturing Issues
FDA, Merck, Daiichi Sankyo, HER3-targeted ADC, patritumab deruxtecan, manufacturing concerns, lung cancer treatment