At AAPS PharmSci 360 2025, held from Nov. 9–12 in San Antonio, Texas, Corey Bloom, PhD, associate director, CMC (chemistry, ...

Have you ever wondered how scientists test new medicines before they reach people? The process must be safe, accurate, and ...

AI drives decision inputs: In 2025, both big pharma and small pharma use advanced predictive modeling, digital twins, and AI-powered analytics throughout R&D and regulatory processes. This reduces ...

Lupin commissions oncology block at Vizag plant, expanding CDMO capabilities for high-potent APIs and oncology drug ...

In the rapidly evolving world of biotechnology and pharmaceuticals, innovation is the key to staying ahead. One of the most ...

AI, ML, and statistical algorithms guide solubilization method selection, demonstrated with compound CVN424. In a poster presentation at AAPS PharmSci 360, by Dineli Ranathunga, PhD, indicates that AI ...

Both The U.S. Department of Health and Human Services (HHS) and the FDA announced the appointment of Richard Pazdur, M.D., as ...

This completion is a crucial requirement in the approval process for a drug.

The US Food and Drug Administration (FDA) has a new chief drug regulator, with industry veteran Dr Richard Pazdur taking the ...

Innovation in drug development has never moved faster! New modalities, real-world evidence, complex patient stratification, and AI are reshaping what’s possible. Yet one of the biggest bottlenecks ...

On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference ...

Finance Income, net, was $0.1 million for the three months ended September 30, 2025, compared to $1.5 million in the same ...