Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that it has submitted a Biologics ...
Pharmaceutical Technology on MSN
Atara receives FDA complete response letter for Ebvallo BLA application
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
The dual inhibition of PD-1 and VEGF pathways by ivonescimab aims to enhance immune response and limit tumor angiogenesis, ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Atara Biotherapeutics stock drops on FDA rejection of EBVALLO BLA for serious post-transplant complication. FDA raises new ...
SHANGHAI and NANJING, China and PLEASANTON, Calif., Nov. 27, 2025 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, ...
Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026 Alignment through recent interactions with CDER on path ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback