Pfizer LITFULO vitiligo Phase 3 results from TRANQUILLO 2 and TRANQUILLO show significant facial and total body repigmentation versus placebo at Week 52, supporting planned FDA and EMA submissions.
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.
The FDA has granted Priority Review to Roche’s Enspryng (satralizumab) for MOGAD, a rare autoimmune CNS disease with no approved treatments, after Phase III METEOROID data showed a 68% relapse risk reduction.
Abbott Libre Duo 10 Day has received FDA authorization as the world’s first dual glucose-ketone biowearable, designed to alert people with diabetes to rising DKA risk while tracking glucose in real time.
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 historic Utebzi FDA approval introduces the first and only oral carbapenem antibiotic for adult patients suffering from complicated urinary tract infections (cUTIs), offering an effective outpatient treatment pathway to combat multidrug-resistant pathogens.
At the ADA 2026 Scientific Sessions, Novo Nordisk unveiled Phase 2 data for zenagamtide (amycretin), demonstrating exceptional blood sugar control and weight loss in type 2 diabetes.
Johnson & Johnson has shared late-breaking results from its Phase 2 JASMINE trial highlighting that nipocalimab achieves a sustained reduction in systemic lupus erythematosus (SLE) disease activity through 52 weeks.
The FDA has approved a label expansion for Johnson & Johnson’s TREMFYA® (guselkumab), cementing its position as the first IL-23 inhibitor with data showing it stops the progression of structural joint damage.
Accord BioPharma and Bio-Thera Solutions achieve a historic FDA approval for ImmGolis, the first interchangeable simponi biosimilar to reach the U.S. market.
