The FDA biologics license application for patritumab deruxtecan in EGFR+ NSCLC has been withdrawn following discussions with ...

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 ...

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Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed ...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

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

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Savara (SVRA) stock in focus as FDA issues a refusal to file letter regarding its marketing application for its lead drug, ...

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 ...

The FDA granted rare pediatric disease designation for OCU410ST, a gene therapy designed to treat ABCA4-associated ...

Summit Therapeutics' Phase 3 trial met the primary goal in lung cancer, showing significant PFS benefit with ivonescimab plus ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary ...