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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, ...
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
Valneva withdrew its chikungunya vaccine applications following a license suspension and data suggesting a probable link to serious adverse outcomes.
ImmunityBio’s IBRX QUILT-2.005 trial tops enrollment forecasts; BLA filing targeted by year-end after positive ANKTIVA+BCG ...
Summit Therapeutics has submitted a Biologics License Application to the FDA for ivonescimab, a first-in-class bispecific ...
RICHMOND, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, has initiated a rolling submission of a BLA to the FDA seeking accelerated ...
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
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