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.
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.
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.
Novo Nordisk Awiqli, the first FDA-approved once-weekly basal insulin for type 2 diabetes, has launched nationwide across more than 70,000 US pharmacies, cutting basal injections from seven per week to one.
The U.S. FDA grants market approval for Moderna’s mFLUSIVA (mRNA-1010) seasonal flu vaccine in adults 50+. Review Phase 3 trial data, efficacy, and rollout details.
The FDA has granted traditional approval to Novartis’ Fabhalta (iptacopan) — the first complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy. Phase III APPLAUSE-IgAN data showed a 48% slower eGFR decline versus placebo over two years.
The LIPFENDRA FDA approval makes Merck’s enlicitide the first once-daily oral PCSK9 inhibitor cleared to lower LDL-C in adults with hypercholesterolemia, including HeFH. Phase 3 CORALreef data showed placebo-adjusted LDL-C reductions of 56–59% at 24 weeks.
Sanofi’s Sarclisa Escena has been approved by the FDA as the first anticancer treatment deliverable via an on-body injector, offering multiple myeloma patients a faster, needle-free-feeling alternative to IV infusions.
