Gain leadership and innovation insights from CEO of the Year finalist at 2025 CPHI Pharma Awards, Mahler Hanns-Christian, who ...

The CNPV pilot program significantly reduces review times, but may challenge safety standards and resource allocation.

FDA will convene a one-day, in-person and virtual public workshop, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine ,” on Tuesday, Dec. 16, 2025 (1). The workshop is ...

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

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

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

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

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

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 program aims to reduce drug review times to 1-2 months, raising concerns about safety and regulatory scrutiny. Critics argue that accelerated timelines may lead to safety issues and strain ...

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

Steve will be monitoring the Rapid Fires: AI/ML in Bioanalysis session on Monday, Nov. 10, 2025 at 3PM CT at AAPS PharmSci ...