The European Medicines Agency (EMA) is touting the ongoing efforts of its Committee for Advanced Therapies (CAT), a panel of expert advisors that EMA said expects to review between three and four ...
Positive opinions covered 104 human medicines in 2025, with 38 new active substances, reflecting sustained innovation throughput and growing representation of complex ...
This marks the first time in company history that a brand name developed using the company's proprietary AI-powered name generation platform, Brandi™, has been approved by a major regulatory agency.
The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical ...