The firm saw an improvement in progression-free survival for patients on the ivonescimab regimen and a trend toward improved overall survival.

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance.

Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...

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 ...

announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO; Headquarters: Rockville ...

NORTH CHICAGO, Ill., April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA ...

NORTH CHICAGO, Ill., April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ...

AbbVie has submitted a Biologics License Application (BLA) to the FDA for TrenibotE (trenibotulinumtoxinE), a novel serotype E botulinum neurotoxin, for the treatment of moderate to severe glabellar ...

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