Artificial intelligence (AI) and machine learning (ML) tools offer an ultra-material-sparing approach to accelerate ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried ...

The emerging prevalence of digitalization is a key topic for manufacturers handling excipients. Digital transformation and ...

In September 2025, the European Commission (EC), together with the Heads of Medicines Agencies (HMA) and the European ...

When we do things like quantum calculations, we look at the confirmer space. So what that does is give us insight into how a ...

The CNPV pilot program reduces review times from 10-12 months to 1-2 months, benefiting generics and biosimilars. Companies must align market access, manufacturing, and post-approval readiness with ...

In particular, Konagurthu says, AI/ML can help sift through a field of drug candidates in which the percentage that are ...

This session will explore best practices for sourcing and managing comparator products in clinical trials. It is designed to ...

To meet rising demand, developers of precision radiopharmaceutical therapies must overcome challenges in global isotope ...

Mechanistic models and hypothesis-driven strategies generate optimized efficient solutions for drug development, says ...

The program, which utilizes a "collaborative tumor board style review process" and a "multidisciplinary team-based evaluation," offers the benefit of reducing application review times from the ...

SMA is a rare, genetic neuromuscular condition that affects people across age groups. With treatment landscapes evolving ...