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

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

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

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

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

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 ...

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