Legacy web forms used for clinical trial recruitment, adverse event reporting, laboratory data collection, and regulatory ...

On April 9, 2026, Oxford BioTherapeutics announced a multi-year collaboration with Bristol Myers Squibb focused on the discovery and development of T-cell engager therapies for solid tumors. 1 ...

Digital twins function as synchronized, real-time operational mirrors, where divergence from the physical process triggers ...

VP of operations and support at Kiteworks, with more than 20 years of experience in IT support and services. Since joining ...

The FDA approved the first generic dapagliflozin tablets, opening a competitive US market for pharma manufacturers and ...

In part 2 of a 2-part interview,Susan Schniepp, Regulatory Compliance Associates Inc., discusses the evolving relationship ...

Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...

This article highlights how quality control microbiology is evolving into a proactive, integrated component of modern contamination control strategies across the biopharmaceutical lifecycle.

Digital predictive modeling is being used to simulate extreme distribution conditions and prioritize mitigation, but hybrid ...

Biocon launches two FDA-approved interchangeable denosumab biosimilars in the US, targeting osteoporosis and bone metastasis in a $5B market.

Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks. In part 1 of ...

Terry Novak, CEO of Benuvia, explores how pharmaceutical and biotech companies can mitigate development risks and accelerate ...