Standards & Regulation

Lecanemab is refused marketing authorization by the European Medicines Agency.

Fertility support programs for gene therapy Medicare patients are being blocked in the US.

Collaboration and thoughtful automation at scale will be critical for unlocking cell and gene therapies for patients

Why companies must tighten their supply chains in light of Chinese anti-espionage laws and other regulatory clampdowns.

Counterfeit deterrents are not yet available in some regions. We speak with Advanco CEO Alf Goebel to find out why.

Following on from deaths attributed to contaminated medicines, here’s how the US Pharmacopeia is promoting testing for DEG and EG.

Preparing for the EU’s new HTA regulation and Joint Clinical Assessment process

Why the FDA must delete its statement that people are not horses (or cows), referring to ivermectin use

In this video interview, Courtney Silverthorn explains the inspiration behind a free regulatory playbook for gene therapy manufacturers.

Production records written using erasable markers, use of expired raw materials, and more.