Novartis Fabhalta Iptacopan FDA Approval Becomes First Complement Inhibitor to Slow Kidney Decline in Primary IgAN
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.
LIPFENDRA FDA Approval: Merck’s Enlicitide Becomes First Oral PCSK9 Inhibitor to Lower LDL-C
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.
GSK Nuvalent Acquisition: GSK Completes $10.6 Billion Nuvalent Acquisition, Expanding Lung Cancer Pipeline
GSK has completed its $10.6 billion acquisition of Nuvalent, Inc., gaining three targeted lung cancer therapies, including zidesamtinib and neladalkib, both currently under FDA review for non-small cell lung cancer.
Johnson & Johnson Q2 2026 Analysis: Company Reports $25.3 Billion in Sales, Raises Full-Year Outlook
This Johnson & Johnson Q2 2026 Analysis breaks down JNJ’s second-quarter results $25.3 billion in worldwide sales, raised full-year guidance, and standout performance from its oncology and immunology drug portfolio.
Merck’s Erbitux BRAF V600E mCRC Regimen Gets EU Approval for First-Line Treatment
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.
AstraZeneca Zegfrovy Deal: AstraZeneca Licenses Dizal’s Oral EGFR Inhibitor for Lung Cancer in Up to $1.5 Billion Agreement
AstraZeneca has secured exclusive worldwide rights to Zegfrovy (sunvozertinib), Dizal Pharmaceutical’s oral EGFR inhibitor for EGFR exon 20 insertion non-small cell lung cancer, in a deal worth up to $1.5 billion. The agreement strengthens AstraZeneca’s EGFR-mutated lung cancer portfolio ahead of potential first-line expansion.
Charles River NGS Services Power Arovella Therapeutics’ ALA-101 Cell Therapy Manufacturing
Charles River Laboratories will supply GMP-grade Next Generation Sequencing (NGS) and viral safety release testing to Arovella Therapeutics for its ALA-101 CAR-iNKT cell therapy. The tie-up follows FDA acceptance of NGS-based viral safety testing in Arovella’s IND for treating CD19+ B-cell lymphomas and leukemias.
Pfizer and Astellas Win FDA Approval for PADCEV Plus Keytruda in Muscle-Invasive Bladder Cancer
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 Wins FDA Approval as First On-Body Injector Cancer Drug
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 FDA PLI Approval Secured for MFG8 Facility to Accelerate Commercial Supply of Autoimmune Therapy
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.