Redacted chemistry review documents in several recent drug approval packages show the US Food and Drug Administration’s thinking on a range of quality issues.
Amgen’s Evenity was the latest monoclonal antibody to encounter growing questions about sequence variants. Meanwhile, Jazz had to convince the...
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?