Labels (device)
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug
CHMP, Labels (device), expansions, Approved
Bayer Seeks to Broaden Nubeqa’s Use in Prostate Cancer with Chemotherapy-Free Treatment Option
Nubeqa, Bayer, prostate cancer, chemotherapy-free, label expansion, ARANOTE trial, darolutamide, androgen deprivation therapy (ADT), metastatic hormone-sensitive prostate cancer (mHSPC)
Incyte Seeks Expanded Approval for Monjuvi Following Successful Phase III Trial in Follicular Lymphoma
Incyte, Monjuvi, follicular lymphoma, Phase III trial, label expansion, tafasitamab, MorphoSys, FDA approval, cancer treatment.
Novo Nordisk Withdraws FDA Submission for Wegovy’s Heart Failure Indication, Plans to Reapply Next Year
Novo Nordisk, Wegovy, FDA submission, heart failure, label expansion, regulatory delay
BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease
BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms
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
Amgen’s Uplizna Achieves Phase 3 Success in Treating Immunoglobulin G4-Related Disease, Paving Way for Label Expansion
Amgen, Uplizna, Phase 3, Immunoglobulin G4-Related Disease, IgG4-RD, Rare Autoimmune Disease, Label Expansion
Takeda’s $5.2B Ariad Deal Yields Label Expansion for Iclusig in Rare Leukemia
Takeda, Ariad, $5.2B deal, Iclusig, Label expansion, Rare form of leukemia
Sarepta’s ELEVIDYS Gaining Ground Amidst Anticipation for Expanded Label Approval
ELEVIDYS, Age, Muscular Dystrophy, Duchenne, Sarepta, Labels (device), Child