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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 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
Rethinking the Architecture of Adverse Event Processing
Deploying AI agents to handle data collection, coding, medical review, and quality-checking makes signal management autonomous at the processing stage. 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

Upperton Receives MHRA License for Sterile Manufacturing Facility
Thursday, September 17, 2026
Upperton has received approval from the U.K. Medicines and Healthcare products Regulatory Agency for a variation to its Manufacturing and Importation ... read more
Hovione Opens New Jersey Spray-Drying Facility
Wednesday, September 16, 2026
Hovione has opened a 31,000-square-foot facility at its East Windsor, New Jersey, campus, adding two commercial-scale spray dryers and doubling the ... read more
Neuland Starts Commercial Peptide Manufacturing Module
Wednesday, September 16, 2026
Neuland Laboratories has begun operations at the first of four planned modules at its commercial peptide manufacturing site in Hyderabad, India. read more
Piramal Adds 4.3-MWp Solar Plant at UK Site
Wednesday, September 16, 2026
Piramal Pharma Solutions is installing a 4.3-MWp ground-mounted solar power plant at its integrated drug-substance and drug-product facility in ... read more
ProBio, Kun Tuo Partner on Advanced-Therapy Trials in China
Wednesday, September 16, 2026
ProBio and Kun Tuo, an IQVIA company, have formed a strategic collaboration to provide development, manufacturing and clinical-operations support for ... read more