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 FDA has approved PADCEV plus Keytruda as the first platinum-free neoadjuvant and adjuvant regimen for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, backed by Phase 3 EV-304 data showing major reductions in recurrence and death risk.
WuXi Biologics’ MFG8 facility in Hebei has successfully cleared a rigorous seven-day U.S. FDA Pre-License Inspection. This crucial WuXi Biologics FDA PLI Approval paves the way for the scaled commercial supply of a highly anticipated blockbuster autoimmune therapy, reinforcing the company’s unblemished 100% FDA PLI success rate and robust global quality standards.
Merck has secured an FDA Breakthrough Therapy designation for enpatoran, an investigational oral TLR7/8 inhibitor aiming to address the high unmet need in lupus patients suffering from active skin manifestations.
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.
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.
