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.
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.
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.
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.
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
The New England Journal of Medicine has retracted the pivotal 2021 clinical trial paper for Amgen’s rare-disease drug Tavneos (avacopan). The retraction follows an FDA investigation revealing undisclosed modifications to patient outcome data after the database was locked and unblinded.
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.
