What Astellas Did Right In Using Real-World Evidence For Prograf Approval
US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.
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Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Pharma industry critics herald the agreement for allowing many manufacturers around the world to make the COVID-19 therapeutic and for its transparency. If Merck can do it, they ask, why can’t other companies?