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Patritumab Deruxtecan BLA Withdrawn After Missing Overall Survival Endpoint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 (NYSE:MRK) and Daiichi Sankyo (OTCPK:DSNKY) (OTCPK:DSKYF) announced Thursday the voluntary withdrawal of their U.S.
Healio2d
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 ...
JD Supra2d
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 ...
Finanznachrichten15d
NS Pharma, Inc.: FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment
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 ...
KXAN15d
FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment
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 ...
Yahoo Finance15d
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 ...