Drug Approval | November 23, 2025
FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
The submissions are supported by data from the Phase 3 KEYNOTE-905 trial
The company will present new data from across over 20 cancer types and multiple treatment settings at European Society for Medical Oncology Congress 2025
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union
Merck has also decided to end the favezelimab clinical development program
The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program
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