Up to $100 million in additional loan proceeds provide additional financial flexibility to advance detalimogene development ...

The FDA has accepted the supplemental Biologics License Application (BLA) for ropeginterferon alfa-2b-njft (Besremi), a ...

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 ...

ImmunityBio, Inc. is upgraded to Buy reflecting improving Anktiva data & potential label expansions in NMIBC and NSCLC. Read ...

The firm at the JP Morgan Healthcare Conference additionally expects a regulatory decision on its gene therapy RGX-121 for Hunter syndrome next month.

Atara Biotherapeutics (NASDAQ: ATRA) has developed Ebvallo (tabelecleucel), a novel second-line immunotherapy for Epstein–Barr virus–positive post-transplant lymphoproliferative disease (EBV-PTLD).

The FDA is expected to decide on treatments for allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia.

In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...

The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.

A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant ...

Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...

The results disclosed in this press release are preliminary and unaudited. The Company expects to report full results for the fourth quarter and year ended December 31, 2025, in late February 2026.