TEZSPIRE Eosinophilic Esophagitis Trial: Amgen, AstraZeneca Report Positive Phase 3 CROSSING Results
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
Abbott Libre Duo 10 Day Wins FDA Authorization as World’s First Dual Glucose-Ketone Sensor
Abbott Libre Duo 10 Day has received FDA authorization as the world’s first dual glucose-ketone biowearable, designed to alert people with diabetes to rising DKA risk while tracking glucose in real time.
Johnson & Johnson’s IMAAVY Nipocalimab-aahu Wins FDA Approval as First-Ever Treatment for Warm Autoimmune Hemolytic Anemia
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.
IQVIA Clinical Decision Support Tool Wins 2026 AI Breakthrough Award for Predictive Modeling Solution of the Year
IQVIA’s AI-enabled Clinical Decision Support Tool, built with Breakthrough T1D, won the 2026 AI Breakthrough Award for Predictive Modeling Solution of the Year after cutting T1D misdiagnosis screening workload by 99.5% and lifting diagnostic yield 127-fold.
Moderna With MSD Announces Intismeran KEYTRUDA Melanoma Trial Hits Phase 3 Endpoints
Merck and Moderna announced that the Phase 3 INTerpath-001 trial of intismeran autogene plus KEYTRUDA met its RFS and DMFS endpoints in resected stage IIB-IV melanoma, the first positive Phase 3 result for an individualized neoantigen therapy.
Genentech Hillsboro Manufacturing Expansion: Roche Subsidiary to Invest $750 Million in New Oregon Device-Fill Facility
Genentech, Roche’s US subsidiary, will invest approximately $750 million to build a new device fill-finish facility at its Hillsboro, Oregon campus, adding 250 manufacturing jobs and doubling the site’s size ahead of a 2031 commercial start.
BioMarin Alesta Therapeutics Acquisition: BioMarin Acquires Alesta to Secure Oral HPP Candidate ALE1 for $275M Upfront
The BioMarin Alesta Therapeutics acquisition secures lead oral asset ALE1 for $275M upfront plus milestones, expanding BioMarin’s rare disease skeletal pipeline.
AstraZeneca Discontinues Volrustomig Phase III Trial in First-Line Metastatic Non-Small Cell Lung Cancer
AstraZeneca has officially stopped its Phase III eVOLVE-Lung02 trial evaluating volrustomig plus chemotherapy in first-line metastatic NSCLC following a recommendation from the Independent Data Monitoring Committee.
Pfizer Valneva Lyme Disease Vaccine Candidate Clears EMA Application Review Milestone
The European Medicines Agency has validated Pfizer and Valneva’s Marketing Authorization Application for PF-07307405, a 6-valent Lyme disease vaccine candidate that showed over 70% efficacy in the Phase 3 VALOR trial.
Bristol Myers Squibb ZENBEXUS Wins FDA Accelerated Approval for Multiple Myeloma
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.