Genentech's Subcutaneous Rituximab Breezes Through US FDA Advisory Committee
Lack of concerns about reformulation of product among either Oncologic Drugs Advisory Committee members or FDA reviewers and the decades-long existence of the molecules raises questions as to why the meeting was needed.
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Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
The latest drug development news and US FDA highlights from our Performance Tracker.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.