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Horizon Lines: A Quarterly Review of NDAs – October- December 2025
This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. read more
Should Sponsors Provide Source Document Templates?
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more
From Service Provider to Strategic Partner
As drug development grows more complex and timelines compress, sponsors require CDMO relationships built on integration, flexibility, and shared accountability read more
An Interview With Franco Negron
Simtra’s capability to support high-volume injectables and lower-volume modalities provides balanced expertise across the sterile injectables landscape. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

VectorBuilder, Lir Partner to Engineer More Manufacturable AAV Capsids
Thursday, August 20, 2026
VectorBuilder and Lir Therapeutics have formed a strategic collaboration to develop adeno-associated virus capsids designed to combine biological ... read more
Charles River, Medigen Partner on Multivalent Enterovirus Vaccine
Thursday, August 20, 2026
Charles River Laboratories International and Medigen Vaccine Biologics Corp. have formed a collaboration to support development of Medigen’s next-... read more
Cytovance Adds Standalone Analytical Services
Wednesday, August 19, 2026
Cytovance Biologics has launched standalone analytical services for biopharmaceutical companies, allowing clients to access analytical testing without... read more
Piramal Pharma Takes Controlling Stake in Yapan Bio
Wednesday, August 19, 2026
Piramal Pharma Ltd. has completed the acquisition of an additional 40.67% stake in Hyderabad-based biologics contract development and manufacturing ... read more
Clinilabs Names Laura Shannon CEO; Founder Gary Zammit Becomes Executive Chair
Tuesday, August 18, 2026
Clinilabs has appointed biopharma executive Laura Shannon as chief executive officer and promoted founder Gary Zammit, Ph.D., to executive chairperson... read more