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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
Status Of AI Regulation On Drug Development
As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. 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
Material-Sparing Strategies for Rapid Development and Scale-Up of Complex Drug Products
In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development. read more

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

Eurofins CDMO Alphora Expands High-Potency Development Capacity in Canada
Friday, August 14, 2026
Eurofins CDMO Alphora has expanded its kilolab and high-potency active pharmaceutical ingredient development and manufacturing capabilities in ... read more
Axtria to Build Industry's Largest Pharma-Specific AI Engineering Team, Scaling to 1,000 by December 2026
Thursday, August 13, 2026
Axtria Inc. announced plans to expand its Forward Deployed Engineering (FDE) organization to 1,000 engineers by December 2026, creating the industry's... read more
Cycle Selects Forma for U.S. Manufacturing of CML Drug Cavhanza
Wednesday, August 12, 2026
Cycle Pharmaceuticals has selected Forma Life Sciences to establish U.S. commercial manufacturing supply for Cavhanza, an FDA-approved orally ... read more
Aurisco Says Yangzhou Site Passes FDA Inspection for Generic Oligonucleotide API
Wednesday, August 12, 2026
Aurisco Pharmaceutical said its Yangzhou, China manufacturing site has passed an FDA pre-approval inspection for inclisiran sodium, describing the ... read more
GXP-Storage Adds Third UK Facility With Raunds Expansion
Tuesday, August 11, 2026
GXP-Storage is expanding its UK operations with a third restricted-access facility in Raunds, Northamptonshire, adding more than 95,000 cubic feet of ... read more