WebJun 9, 2024 · AUSTIN, Texas - June 9, 2024 - ( Newswire.com ) Direct Biologics , a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post … WebDec 29, 2024 · Yes, but ONLY for FDA-approved biological products specifically designated as interchangeable, as found in The Purple Book. On July 28, 2024, Semglee (insulin glargine) was approved as an interchangeable biologic with Lantus. It was the first interchangeable biosimilar approved in the US, as well as the first interchangeable …
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