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CAPR updates FDA on Deramiocel BLA, plans HOPE-3 CSR filing in February

Capricor Therapeutics CAPR recently provided a regulatory update on its Biologics License Application (BLA) for Deramiocel, ...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data

FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in ...
Berkshire Eagle

FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)

PLYMOUTH MEETING, Pa., Dec. 29, 2025 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from ...
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Inovio announces US FDA accepted BLA for INO-3107

INOVIO (INO) announced that the U.S. Food and Drug Administration, FDA, accepted the company’s Biologics License Application, BLA, for INO-3107 for review as a potential treatment for adults with RRP.