Standards & Regulation

Biosimilars have been available in Europe for years. Is the US still lagging behind?

Though in theory, biosimilars should help improve medicines access, what challenges still stand in the way of therapeutic equality and equity?

Moderna’s new CFO lasts one day in the job as investigation comes to light.

Medicare publishes policy for amyloid mAbs and Alzheimer’s disease. It’s not good news for Aduhelm.

How an initiative from EFPIA and a new public database on chemical substances could reduce animal experiments.

We find out how technology is enabling remote inspections in the pharma industry.

With the FDA still behind on inspections, manufacturers need to uncover their own blindspots.

Reconfigure. Redefine. Why modular cleanroom furniture is essential for a changing pharmaceutical market.

That which we call rosaimab by any other name would find regulatory approval and commercial success. Or would it?

What is going on with Aduhelm? And why is the drug seen by some to be controversial?