The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...
Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for ...
STOCKHOLM, Jan. 13, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's ...
The suspension of the license requires Valneva to immediately stop shipping and selling Ixchiq in the US. The Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER) ...
On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a ...
Tabelecleucel, an allogeneic, EBV-specific T-cell immunotherapy, works by targeting and eliminating EBV-infected cells.
Meghana Keshavan covers biotech and contributes to The Readout newsletter. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has ...
Please provide your email address to receive an email when new articles are posted on . Clesrovimab is a monoclonal antibody that protects against RSV subtypes A and B. The FDA set a PDUFA date for ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback