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Patritumab Deruxtecan BLA Withdrawn After Missing Overall Survival Endpoint
Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance.
Merck, Daiichi Sankyo pull marketing application for lung cancer therapy
Merck (MRK) stock falls as the company withdraws U.S. marketing application for lung cancer therapy HER3-DXd developed with ...
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FDA grants rare pediatric disease designation for Stargardt disease gene therapy
The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...
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FDA Approves BLA for Novavax’s COVID-19 Vaccine
Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...
Savara Shares Slide After FDA Declines Drug Application
Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter ...
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FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment
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 ...
Nasdaq1mon
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
BOTOX® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units ...
Yahoo Finance1mon
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
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 ...
Yahoo Finance1mon
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
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 ...
Pharm Exec1mon
AbbVie Submits Biologics License Application to FDA for Novel Serotype E Botulinum Neurotoxin in Moderate to Severe Glabellar Lines
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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AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
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