The US-led Project Orbis initiative was used to authorize six new cancer medicines between 1 January and 5 December this year, while nine indication extensions were granted under the scheme. One medicine had its accelerated approval for a label expansion converted to a full marketing authorization.
One of the main aims of Project Orbis, which was established by the Food and Drug Administration in 2019, was to provide a framework for international regulators to concurrently review filings for cancer drugs
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?