Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
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