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Engaging with Regulators for Single-Arm Oncology Research Trials
When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more
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

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

Piramal Pharma Solutions Expands Turbhe Peptide Facility With New Spray Drying Suite
Tuesday, August 04, 2026
Piramal Pharma Solutions has expanded its peptide API facility in Turbhe, India, with a new spray drying suite designed to support challenging ... read more
Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate
Monday, August 03, 2026
Polpharma Biologics announced that the FDA and the EMA have accepted for review the Biologics License Application (BLA) and Marketing Authorization ... read more
Codis Completes Nottingham Deal to Expand Europe’s Spray Dry Network
Monday, August 03, 2026
Codis has completed its acquisition of Catalent’s Nottingham, UK facility, a move that expands the company’s integrated spray dry offering in Europe ... read more
Genezen, Raiden Science Foundation Partner on UBA5 Gene Therapy Manufacturing
Monday, August 03, 2026
Genezen and the Raiden Science Foundation have announced a manufacturing partnership for an AAV9 gene replacement therapy for UBA5 disorder, moving ... read more
Resilience and Lilly Invest $750M to Increase U.S.-Manufactured Medicine Supply
Monday, August 03, 2026
Resilience announced it has expanded its strategic partnership with Eli Lilly and Company to increase U.S. production of critical medicines featuring ... read more