United States Food and Drug Administration
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FDA Publishes Updated Draft Guidance on Clinical Trial Diversity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
AbbVie’s Duopa Successor in Parkinson’s Rejected Again Due to Third-Party Manufacturer Issues
AbbVie, Duopa, Parkinson’s disease, FDA rejection, third-party manufacturer, ABBV-951, carbidopa, levodopa, subcutaneous pump device
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.
AbbVie’s Parkinson’s Disease Therapy Rejected by FDA Due to Third-Party Manufacturer Issues
AbbVie, Parkinson’s disease, FDA, ABBV-951, foscarbidopa, foslevodopa, third-party manufacturer, regulatory issues
Lilly’s Zepbound Shows Promise in Resolving Sleep Apnea in Obese Patients, Strengthening Case for Label Expansion
Zepbound, tirzepatide, sleep apnea, obesity, label expansion, Eli Lilly, SURMOUNT-OSA program, weight loss, FDA approval
Argenx’s Vyvgart Hytrulo Secures Second US Approval for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Vyvgart Hytrulo, Argenx, FDA Approval, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Disease, Peripheral Nervous System Disorder
FDA Approves Adagrasib (Krazati) with Cetuximab for KRAS G12C-Mutated Colorectal Cancer
Adagrasib, Krazati, Cetuximab, KRAS G12C, Colorectal Cancer, FDA Approval, Bristol Myers Squibb, Mirati Therapeutics, Amgen, Lumakras
Eli Lilly’s Zepbound Shows Promise in Treating Sleep Apnea, Seeks FDA Approval
Zepbound, Eli Lilly, sleep apnea, FDA approval, Novo Nordisk, Wegovy, weight loss, diabetes, pharmaceuticals