Keeping Track: Kybella, Ixinity, Raplixa Approved; Three 'Complete Responses' Surprise No One
The latest drug development news and highlights from our FDA Performance Tracker.
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FDA approved Breo Ellipta as a once-daily treatment for asthma, a new indication for a drug that has been on the market since October 2013 for COPD.
FDA is conducting additional inspections of the site of a hypersensitivity study the agency requested in 2008; concerns about the study derailed a committee review in 2013.
Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?