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.

We look forward to working with the FDA throughout the review process to support this potential approval.” The full submission of the rolling BLA was completed as the company had previously guided in ...