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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
How Sports Stars and Drugs Keep Getting Reinvented
Reinvention is everywhere. Products get updated, industries change course, and ideas we once treated as finished suddenly come back in a new form. Something that felt permanent five years ago can look completely different today, redesigned for a new audience or a new moment. read more
The Operational Foundations That Characterize Regulatory Leaders
Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. read more
Horizon Lines: A Quarterly Review of NDAs – January-March, 2026
The NDAs approved during the first quarter of 2026 have been divided into the dosage forms Injection, Tablets, Capsules, Oral solution, Gas, and other. read more

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

Valion Bio Highlights Scale-Up And Oncology Plans For Entolimod Biodefense Platform
Tuesday, July 14, 2026
Valion Bio reported a set of strategic developments around its Toll like receptor 5 (TLR5) agonist Entolimod, underscoring plans to build an ... read more
Formycon And OneSource Sign Biosimilars Manufacturing Partnership
Tuesday, July 14, 2026
Formycon AG and OneSource Specialty Pharma have entered a strategic manufacturing partnership to support Formycon’s biosimilar programs for global ... read more
Charles River Provides NGS Services to Arovella Therapeutics
Tuesday, July 14, 2026
Charles River Laboratories International announced a collaboration with Arovella Therapeutics, a biotechnology company, to provide Good Manufacturing ... read more
Kindeva Appoints Chief Transformation Officer
Monday, July 13, 2026
Kindeva announced the appointment of Brok Weichbrodt as Chief Transformation Officer to strengthen operational excellence, scale execution, and ... read more
Axplora Manufacturing Sites Earn EcoVadis Ratings Across European Network
Thursday, July 09, 2026
Axplora reported updated EcoVadis sustainability ratings for four of its European manufacturing sites, with one site achieving platinum status and ... read more