FDA Approves Atezolizumab for Stage III dMMR Colon Cancer
On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in…
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FDA Sets May 1 PDUFA Action Date for uniQure’s Gene Therapy
The FDA has established a May 1 target action date under the Prescription Drug User…
Study Links Pulmonary Hypertension to Cognitive Decline
A study by University of Pittsburgh and UPMC researcher-clinicians has uncovered a connection between pulmonary…
Karyopharm to Auction Itself Amid Bankruptcy
Karyopharm, a company facing significant debt issues, is set to be the lead bidder in…
FDA Approves Generic HIV Prevention Shot by Dr. Reddy’s Laboratories
After months of anticipation, the Food and Drug Administration gave tentative approval to Dr. Reddy’s…
Sourcing Strategies for API Supply Chain Resilience
The pharmaceutical supply chain, which moves drugs from raw materials to patients, begins with Active…
Technology Transfer Essential for Manufacturing Readiness
Successful technology transfer involves more than just completing documentation; it requires ensuring that the receiving…
10x Genomics Launches Sentira for Single-Cell Analysis
10x Genomics has launched Sentira Single Cell, a cloud-based analysis tool powered by Anthropic’s Claude…
Navigating Complexity in Biologics Development
The biologics industry is facing increased complexity as pipelines expand beyond monoclonal antibodies to include…
Keytruda Biosimilars Face Market Challenges
A patent cliff is approaching for Merck’s flagship blockbuster Keytruda, which could open the door…