AstraZeneca AZN announced that the FDA has approved its blockbuster drug, Imfinzi (durvalumab), for a bladder cancer indication in the United States. Imfinzi is approved in combination with ...

The US Food and Drug Administration (FDA) has approved AstraZeneca's human monoclonal antibody Imfinzi (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as an ...

AstraZeneca’s hopes of positioning its PD-L1 inhibitor Imfinzi as a post-surgery therapy for people with earlier-stage lung cancer have taken a knock, although it performed well in a bladder ...

Antibody-drug conjugates combined with immunotherapy have redefined the standard of care for advanced bladder cancer, ...

AstraZeneca (AZ) has announced that its Imfinzi (durvalumab) perioperative regimen has been approved by the US Food and Drug Administration (FDA) to treat adults with muscle-invasive bladder cancer ...

“Today’s approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant ...

4 Imfinzi is also approved in Brazil in this setting based on the NIAGARA results. Regulatory applications are currently under review in the EU, Japan and several other countries. Bladder cancer ...

AstraZeneca has revealed the data for Imfinzi in muscle-invasive bladder cancer (MIBC) that it hopes will be enough to secure FDA approval – although the jury is out on that. The clinical ...

The FDA approved Imfinzi with chemotherapy for neoadjuvant treatment in muscle invasive bladder cancer, followed by adjuvant Imfinzi post-cystectomy. The phase 3 NIAGARA trial demonstrated significant ...

"Today’s approval for IMFINZI represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant ...