Aug 24, 2025 · However, these timelines vary considerably across regions, influenced by agency capacity, regulatory pathways, national guidelines, and priority programs.

This analysis is essential for understanding the variations in approval timelines, documentation requirements, and regulatory standards across regions such as the United States, Europe, and India.

Mar 26, 2025 · This report from the IQVIA Institute - Global Trends in R&D 2025: Progress in Recapturing Momentum in Biopharma Innovation - assesses the trends in R&D funding, clinical trial …

6 days ago · Novel Drug Approvals for 2025 What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S.

Our comparative analysis reveals significant differences in the criteria and processes for generic drug approval among these countries. In the United States, the Abbreviated New Drug Application …

Aug 29, 2025 · Summary Selected drug approvals anticipated in the 12-month period covering the third quarter of 2025 through the second quarter of 2026 are reviewed. The analysis emphasizes drugs …

Those developments have uncovered large “captagon” manufacturing sites in the country, possibly disrupting the drug’s supply, although the latest available seizure data, from 2024 and early 2025, …

Jun 3, 2025 · Explore the 2025 Asia drug registration reforms, comparing critical updates in Hong Kong, China, and ASEAN. Learn how to optimize approval timelines and compliance strategies.

Dec 15, 2025 · Drug Discovery Onlines 2025 Top 5 most consequential shifts affecting this rapidly evolving field, including NAMs, AI, Individualized Therapies, Innovating China, and Early-stage …

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change.