Standards & Regulation

It’s relatively simple: Follow cGMP, keep your facilities clean, keep vermin out, and don’t sell unapproved products…

An inside view of the pharmaceutical industry in China. Where has it been, where does it stand, and where is it going?

It’s been a busy time for infectious disease vaccine news in Europe.

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.