Main opportunities include integrating process validation with modern, science-based approaches, utilizing risk-based strategies like QbD, DOE, and PAT, and adhering to global regulatory standards to ...

1. FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results. News release. FDA. April 13, 2026.

The key market opportunities lie in providing training for analytical method validation, focusing on drug substance and product analysis. This includes lab procedure transfer techniques, compendial ...

End-to-end digital twins for continuous automated manufacturing could slash production costs compared to batch manufacturing.

Amazon has pitched an AI-powered drug discovery platform to the biopharma industry that it says brings together computational ...

In the race of innovative drug R&D, whether for antibodies, peptides, or novel binding proteins, the efficiency of early-stage molecule discovery is always the key factor determining project success ...

Bringing a single drug to market can take more than a decade and cost billions of dollars, with fewer than one in ten candidates successfully reaching approval. Against this backdrop, generative AI is ...

Kim Trautman, an industry expert, shares some practical tips and tools for companies to navigate FDA’s new inspection process ...

Bunkerhill Health, an agentic AI company building healthcare’s system of action, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a new national billing code ...

Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that ...

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent ...

Several patient and disease advocacy organizations have responded to the Center for Drug Evaluation and Research's (CDER) ...