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…
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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…
FDA Delays PDUFA Action on Agios’ Mitapivat sNDA for SCD
The FDA has delayed a decision on Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) seeking…
AstraZeneca Restructures, Alnylam Faces Challenges, Regeneron Reports Success
AstraZeneca is set to redeploy resources as part of a new restructuring program aimed at…
FDA Issues Revised Guidance on Drug Delivery Devices
The FDA has announced a revised draft guidance for industry titled “Essential Drug Delivery Performance…
Neuralink’s Blindsight Vision Implant Faces Clinical Readiness Questions
Neuralink’s plans for a brain implant designed to restore vision have gained attention following a…