draft guidance

accelerated
Pharma

FDA drafts plan to cut down on biosimilar testing requirements

The FDA's newest draft guidance reinforces its stated commitment to streamlining biosimilar drug development by removing certain testing requirements.
Zoey Becker Mar 9, 2026 5:25pm
Person using social media on mobile phone by Getty Images

PhRMA calls for edits to 'overly simplistic' misinformation text

Sep 16, 2024 12:15pm
FDA Building 2

FDA shares advice on bioequivalence of different dosage forms

Aug 24, 2021 7:45am
Zolgensma

Novartis' £1.79M gene therapy Zolgensma scores NICE backing

Mar 8, 2021 10:45am