BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)-- The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE ...

The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

(RTTNews) - The Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan, co-developed by Merck & Co Inc. (MRK) and Daiichi Sankyo Company, Limited (DSKYF ...

Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed ...

The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for ...

has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing ...

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

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 ...

With an unchanged $10 price target, H.C. Wainwright maintained its Buy rating on Sangamo Therapeutics, Inc. (NASDAQ: SGMO) on ...

The biotechnology company said the FDA approved the biologics license application for Nuvaxovid to prevent Covid-19 in adults ages 65 and up and individuals ages 12 through 64 who have at least one ...

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 ...

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 ...