AbbVie JUVMO (tavapadon) has received FDA approval as the first selective D1/D5 receptor agonist for adults with Parkinson’s disease. AbbVie expects U.S. availability in October 2026.
Lilly Olumiant Alopecia Areata has received FDA approval for pediatric patients 12 and older, expanding treatment access based on Phase 3 BRAVE-AA-PEDS trial results showing substantial scalp hair regrowth in adolescents with severe alopecia areata.
The FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes. Backed by the QWINT Phase 3 program spanning over 3,400 patients, Onswik becomes Lilly’s fourth global approval for the weekly insulin, expected to launch via the KwikPen in the coming months.
Novartis has received a positive CHMP opinion recommending European marketing authorization for Cosentyx (secukinumab) in adults with polymyalgia rheumatica, based on Phase III REPLENISH data showing sustained remission and steroid-sparing effects.
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
The FDA has approved a label update cutting Amgen IMDELLTRA monitoring time for the first two doses from 22-24 hours to 6-8 hours, a change aimed at easing treatment burden for ES-SCLC patients in community oncology settings.
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for HER2-positive metastatic breast cancer, marking AstraZeneca and Daiichi Sankyo’s first new EU regimen in this setting in over a decade, backed by DESTINY-Breast09 data showing a 44% reduction in progression or death risk.
Johnson & Johnson’s IMAAVY nipocalimab-aahu has received FDA approval as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), based on durable hemoglobin response data from the Phase 2/3 ENERGY study.
The FDA has granted accelerated approval to Bristol Myers Squibb ZENBEXUS (iberdomide), the first CELMoD therapy ever cleared, paired with daratumumab and dexamethasone for multiple myeloma patients as early as first relapse.
