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US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.
A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
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