Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting
According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
Lupin updates on shipment of Mirabegron ER Tablets
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
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