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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
Extreme Language Ultra-High Potency
The newest generation of small-molecule therapies bring containment needs well beyond those of conventional HPAPIs. What does this mean for the pharma lexicon – and the pharma landscape? 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
An Interview With Brian Morrissey
In this interview we spoke to Brian Morrissey, General Manager of Gaelic Laboratories, about the strategy behind their acquisition of Athlone Laboratories, and its impact. read more

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

Lifecore Adds Seventh Late-Stage Commercial Manufacturing Program
Thursday, September 03, 2026
Lifecore Biomedical has signed an agreement with an undisclosed global pharmaceutical company to transfer manufacturing of a currently marketed ... read more
Fortrea Agrees to $45M Purchase of Worldwide Early-Phase Unit
Thursday, September 03, 2026
Fortrea Holdings has agreed to acquire the Early Phase Services division of Worldwide Clinical Trials in an all-cash transaction valued at about $45 ... read more
Northway Biotech Opens $72 Million Cell-Therapy CDMO in Vilnius
Thursday, September 03, 2026
Northway Biotech has opened a $72 million cell-therapy and personalized-medicine contract development and manufacturing facility in Vilnius, Lithuania... read more
ARPA-H Awards Up to $125M for Distributed RNA Medicine Manufacturing
Thursday, September 03, 2026
The Advanced Research Projects Agency for Health has selected five teams for a program intended to develop automated, distributed manufacturing ... read more
Evonik Invests $109 Million in Vancouver Lipid Drug Facility
Tuesday, September 01, 2026
Evonik will invest more than 150 million Canadian dollars, or about $109 million, to build a new good manufacturing practice drug-product facility in ... read more