US FDA First's RMAT Designation: Humacyte Got A 'Quick Response'
Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.
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A number of pivotal studies are expected to report top-line data in the third quarter. Here, with the help of Informa Pharma's Biomedtracker, we take a look at eight of those likely to be major catalysts for their sponsors.
CBER Director Peter Marks says the center implemented a lot in a short amount of time for the RMAT pathway.
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.