FDA okays AstraZeneca’s bladder cancer drug Imfinzi Plus BCG

First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death

FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough

The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term

Merck’s KEYTRUDA combo wins key EU backing for bladder cancer treatment

The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026

Imfinzi-based regimens deliver major survival gains in muscle-invasive bladder cancer

The study has shown that perioperative treatment with Imfinzi (durvalumab), alone or in combination with other immunotherapy agents

Merck wins FDA priority review for KEYTRUDA bladder cancer combo expansion

If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev

Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline

Johnson & Johnson reports promising early results for targeted bladder cancer therapy

FGFR alterations are prevalent in early-stage bladder cancer, appearing in roughly 70% of intermediate-risk and 40% of high-risk NMIBC tumors

Relmada’s NDV-01 shows strong 12-month results in hard-to-treat bladder cancer

The study showed a 76% complete response (CR) rate at 12 months, rising to 95% at any time for high-risk NMIBC patients

Pfizer and Astellas report groundbreaking results in muscle-invasive bladder cancer trial

FDA endorses Relmada’s registrational strategy for bladder cancer therapy