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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, ...
Valneva has made the decision to withdraw the Biologics License Application for its chikungunya vaccine Ixchiq®.
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates ...
Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that it has submitted a Biologics ...
ImmunityBio’s IBRX QUILT-2.005 trial tops enrollment forecasts; BLA filing targeted by year-end after positive ANKTIVA+BCG ...
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
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