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.
The European Commission has approved Merck’s Erbitux BRAF V600E mCRC combination regimen cetuximab plus encorafenib and FOLFOX as first-line therapy for metastatic colorectal cancer with the BRAF V600E mutation, based on Phase 3 BREAKWATER data showing a 51% reduction in risk of death versus standard chemotherapy.
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.
Marking a major milestone, Novartis receives European Commission approval for Itvisma, introducing a fixed, one-time gene replacement therapy for a broad population of spinal muscular atrophy patients across Europe
AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Pfizer Inc. announced the landmark FDA expansion of IBRANCE (palbociclib) in combination with anti-HER2 and endocrine therapies for HR+, HER2+ metastatic breast cancer frontline maintenance following successful Phase 3 PATINA trial results.
