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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
Hasty Decisions, Runaway Projects
Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more
An interview with Franco Negron
In this interview, we spoke with Franco Negron, CEO of Simtra, about how the company is advancing its position as a premier CDMO for sterile injectables while preparing for the next wave of complex biologics. read more
How Real-Time Data Analytics Can Address Common Pain Points in Clinical Trials
Major issues in clinical oversight are latency and heterogeneity across systems including formats, identifiers, coding conventions, and timing of updates. read more

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

Phanes, Merck Expand Trial Pact to Test CD47 Bispecific with KEYTRUDA in 1L Biliary Tract Cancer
Tuesday, July 21, 2026
Phanes Therapeutics has expanded its clinical trial collaboration and supply agreement with Merck to evaluate spevatamig in combination with KEYTRUDA ... read more
Lonza, Engitix Sign License Deal to Advance ECM-Targeted ADC Therapies
Tuesday, July 21, 2026
Lonza and Engitix have entered a licensing agreement aimed at advancing a new generation of antibody-drug conjugates (ADCs) that target the ... read more
Redwire Opens Indiana Space R&D Hub to Advance Drug Development and Human Health
Tuesday, July 21, 2026
Redwire Corporation has opened a new 30,000 square foot, state-of-the-art research and microgravity payload development facility in Georgetown, ... read more
CDMO eXmoor Pharma, Evox Complete Tech Transfer for Exosome Gene Editing Platform
Tuesday, July 21, 2026
eXmoor Pharma and Evox Therapeutics have completed a technology transfer program for Evox’s exosome-enabled gene editing platform, including its MSH3-... read more
Clinigen Names Industry Veteran as New CEO
Tuesday, July 21, 2026
Clinigen has appointed Greg Skalicky as Group Chief Executive Officer, effective July 20, 2026, succeeding Dr. Varun Sethi, who has served as Acting ... read more