Qualitative Concept
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
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
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 Approves EPKINLY (Epcoritamab-Bysp) for Relapsed or Refractory Follicular Lymphoma
EPKINLY, epcoritamab-bysp, follicular lymphoma, FDA approval, relapsed or refractory, bispecific antibody, T-cell engaging, subcutaneous treatment
AbbVie’s Epkinly Enters Follicular Lymphoma Market, Competing with Roche’s Lunsumio
Epkinly, Lunsumio, follicular lymphoma, bispecific antibodies, AbbVie, Roche, FDA approval, cancer treatment
FDA Publishes Updated Draft Guidance on Clinical Trial Diversity
FDA, Clinical Trials, Diversity, Inclusion, Medical Products, Racial and Ethnic Representation
Sarepta Therapeutics: Next Steps After Full FDA Approval for Duchenne Muscular Dystrophy Gene Therapy
Sarepta Therapeutics, Duchenne muscular dystrophy, gene therapy, FDA approval, Elevidys, microdystrophin, ambulatory patients, non-ambulatory patients, pipeline development, rare diseases, genetic medicine.
Wave Life Sciences Achieves Breakthrough in Huntington’s Disease Treatment with WVE-003, Eyes Accelerated Approval
Wave Life Sciences, Huntington’s disease, WVE-003, Phase Ib/IIa study, accelerated approval, mutant huntingtin protein, allele-selective silencing, RNA medicine
Exsilio Therapeutics Launches with $82 Million to Develop mRNA-Based Genomic Medicines Under Tal Zaks’ Leadership
Exsilio Therapeutics, mRNA, genomic medicines, Tal Zaks, gene therapy, gene editing, lipid nanoparticle delivery, redosing, safety profile, gene therapy approval