Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application ...

Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.

Capricor initiated its rolling submission process for the deramiocel ... Additionally, subject to the FDA approval of the deramiocel BLA for DMD cardiomyopathy, Capricor would be eligible to ...

The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.

(RTTNews) - Replimune Group, Inc. (REPL), Tuesday announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for RP1 in combination with Nivolumab for the ...