Tag: bladder cancer
Japan’s MHLW grants priority review for PADCEV and KEYTRUDA combo in urothelial cancer
In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has awarded ... Read More
Advancing bladder cancer treatment: EMA scrutinizes Astellas-Pfizer’s innovative therapy
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review ... Read More
Ferring Pharmaceuticals begins treatment of first US patient with ADSTILADRIN
Ferring Pharmaceuticals has announced that the first patient in the United States suffering from high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) has been ... Read More
EarlyTect BCD test : Promis Diagnostics gets FDA breakthrough designation
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and Drug Administration (FDA) as a urine-based diagnosis ... Read More
Ferring bags Adstiladrin FDA approval in non-muscle invasive bladder cancer
Swiss biopharmaceutical company Ferring Pharmaceuticals has received approval for its Adstiladrin (nadofaragene firadenovec-vncg) gene therapy from the US Food and Drug Administration (FDA) for the treatment ... Read More
Aura Biosciences begins dosing in belzupacap sarotalocan phase 1 trial in NMIBC
Aura Biosciences said that it has dosed the first patient in a phase 1 clinical trial of its first virus-like drug conjugate (VDC) — belzupacap ... Read More
Aura Biosciences gets FDA fast track status for belzupacap sarotalocan
Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration (FDA) for the treatment of non-muscle invasive ... Read More
PADCEV, KEYTRUDA combination for advanced bladder cancer gets FDA breakthrough therapy status
PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) has been ... Read More
Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer
Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) ... Read More