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Latest From Genentech, Inc.
The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.
Office of Inspector General report explores the orphan drug status of a set of blockbuster drugs with the highest level of spending in Medicare.
US FDA’s Oncology Center of Excellence is eager to pilot test ‘Drug Development Snapshots’ as a potential tool to optimize communication for drugs receiving the Breakthrough Therapy Designation. That may be an early next step in the effort to enhance the expedited pathway.
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