regulatory

News

The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.

News

Insmed gets EU recommendation for first non-cystic fibrosis bronchiectasis therapy Brinsupri, plus other CHMP decisions.

News

The FDA has named the first products to take advantage of its recently announced Commissioner's national priority voucher programme.

News

The regulatory authorities in the UK and US have agreed to work more closely together on the regulation of medical technologies and AI.

Oncology

Radiopharmaceutical development must move beyond fixed paradigms toward patient-specific, data-driven optimisation.

News

In another effort to boost domestic drug manufacturing, the FDA is piloting fast-track reviews for generics tested and made in US facilities.