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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

Arcturus, Thermo Fisher Partner on Phase 3 Manufacturing for Cystic Fibrosis mRNA Therapy
Thursday, July 02, 2026
Arcturus Therapeutics has entered a strategic collaboration with Thermo Fisher Scientific to support late-stage development and potential ... read more
Lonza Acquires TfR1 Blood-Brain Barrier Technology from Nona, Expands Collaboration
Thursday, July 02, 2026
Lonza has acquired rights to Nona Biosciences’ transferrin receptor (TfR1)-based blood-brain barrier (BBB) technology and expanded its existing ... read more
UC Irvine, GlyTR Advance AAV-Based CAR-T Program with ProBio Manufacturing Support
Thursday, July 02, 2026
The University of California, Irvine (UC Irvine) and GlyTR Therapeutics are advancing a preclinical CAR-T program targeting solid tumors, supported by... read more
Halozyme Appoints David Ramsay as President Drug Delivery
Wednesday, July 01, 2026
Halozyme Therapeutics announced the appointment of David Ramsay as President Drug Delivery, effective June 30, 2026. read more
Rezon Bio Appoints Chief Business Officer to Accelerate Global Commercial Expansion
Wednesday, July 01, 2026
Rezon Bio announced the appointment of Dr. Hubert Scholze as Chief Business Officer (CBO), effective July 1, 2026. read more