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The FDA does not have a formal legal category called bio-better. A bio-better is an improved biologic that files a full Biologics License Application (BLA) as a new molecular entity under Section 351(a) of the Public Health Service Act, rather than as a biosimilar under the abbreviated 351(k) pathway created by BPCIA

It is about durability

Patients were losing weight without even trying

Role of receptor interacting protein (RIP) kinases in cancer

It depends on your specific risk, your procedure, and the anesthesia plan, which is why it belongs to your surgical team and prescriber together, never to a self-made call