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FDA Approves Atezolizumab for Stage III dMMR Colon Cancer

November 3, 2026
On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. This approval may enhance treatment options for patients with this…
Laboratory setting for gene therapy research

FDA Sets May 1 PDUFA Action Date for uniQure’s Gene Therapy

November 3, 2026
The FDA has established a May 1 target action date under the Prescription Drug User Fee Act (PDUFA) for uniQure’s Huntington’s disease gene therapy candidate ifezuntirgene inilparvovec, following the acceptance of the company’s Biologics License Application (BLA) under Priority Review. This decision marks a significant turnaround from previous agency opposition. The FDA has indicated plans…

Baxter Warning Letter Ends a $50M Cephalosporin Line With 60% Margins

November 3, 2026
Baxter International is shutting down a cephalosporin business that, by its own numbers, brings in about $50 million in sales and $30 million in operating income this year. The reason is an FDA warning letter to its Round Lake, Illinois injectables plant, and the bill for that letter lands partly on the hospitals and distributors…
Brain MRI scan showing structural changes

Study Links Pulmonary Hypertension to Cognitive Decline

November 3, 2026
A study by University of Pittsburgh and UPMC researcher-clinicians has uncovered a connection between pulmonary hypertension (PH) and cognitive decline. The research team conducted a multimodal investigation involving brain MRI studies, blood-based molecular profiling, and functional studies in mouse models, linking specific brain abnormalities in PH to inflammatory processes affecting both the lungs and heart.…

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