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Latest From Michael Cipriano
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.
Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.
CDER Director Woodcock warns that incentivizing ANDA development with breakthrough-style approach could have unintended consequences, such as more citizen petitions designed to delay generic availability.
FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.
Jeffrey Shuren and Janet Woodcock tell Senate committee that agency is more concerned with implementing combination product provisions of the 21st Century Cures Act.
Nothing's even in Phase II yet, but sponsors and US government researchers remain optimistic.