Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
The company received one observation in the Form-483
Now approved for both acute and chronic HCV in adults and children aged 3 and above
The company received 1 (One) observation in the Form-483
Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery
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