Monograph Development: Why and When to Participate

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.