Nasdaq

European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder ...

NEW YORK& TOKYO---- Pfizer Inc. and Astellas Pharma Inc. today announced that on January 26 the European Medicines Agency validated for review a Type II variation application for PADCEV ® with ...
Pharmabiz

EMA validates Type II Variation marketing application for Enhertu as post-neoadjuvant treatment for patients with HER2 positive earlybreast cancer

EMA validates Type II Variation marketing application for Enhertu as post-neoadjuvant treatment for patients with HER2 positive earlybreast cancer: Tokyo Saturday, February 21, 20 ...
Yahoo Finance

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

TOKYO & MUNICH, January 19, 2026--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) in ...
Business Insider

EMA Validates Type II Variation For Astellas' XTANDI For Treatment Of Prostate Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) said that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI (enzalutamide) for the treatment of patients with ...
Pharmabiz

EMA validates Type II Variation marketing authorization application of Datroway as first-line treatment for patients with metastatic TNBC who are not candidates for immunotherapy

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for Datroway (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult ...
Nasdaq

European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder ...

TOKYO and NEW YORK, Jan. 26, 2024/ PRNewswire/-- Astellas Pharma Inc. and Pfizer Inc. today announced that on Jan. 26, 2024 the European Medicines Agency validated for review a Type II variation ...
WGN-TV

European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder ...

The Type II variation application for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found the combination improved ...