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 BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
Mesoblast says FDA feedback supports filing plans for its cell therapy to treat chronic back pain, showing reduced pain and ...
ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...
AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to ...
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 ...
The FDA has issued a second complete response letter to Atara Biotherapeutics for its biologicals license application of ...
PARAMUS, N.J., March 10, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that ...
FDA's release of CRLs for unapproved products does not appear to be limited to situations where the application's existence had been publicly disclosed or acknowledged. Based on our review of those ...
On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...
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