Standards & Regulation

The FDA has approved just three biosimilars in 2021 – but the approvals could shake up the field as discussions around interchangeability intensify.

After nine months of speculation about who will be the next FDA commissioner, we may finally be close to a decision.

We speak with the authors of two studies into extreme increases in US drug pricing, and attempts by lawmakers to bring the price-jackers into line.

Pfizer-BioNTech COVID-19 vaccine receives full FDA approval.

Pharma wants to empower patients to make informed healthcare decisions, but patients also need to be protected from misinformation.

AI is expanding into medicine. Are the world’s regulators ready?

Sandoz’s Pierre Bourdage talks to us about biosimilars and how uptake can be boosted.

Advanz Pharma is fined for substantially hiking the price of a generic drug.

When it comes to conducting clinical trials in emerging geographies, there are four key challenges to consider.

How can we ease the process of taking ATMPs to clinical trials? Two experts lay out the key considerations.