Nasdaq

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) ...
PharmiWeb

Leqembi® (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease (AD) in the UK is ...

Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment ...
Yahoo Finance

DATROWAY® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for ...

TOKYO & MUNICH, December 18, 2025--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY ® (datopotamab deruxtecan) ...
Yahoo Finance

ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

Submission based on three phase 2 trials where Daiichi Sankyo and AstraZeneca’s ENHERTU showed clinically meaningful responses across a broad range of tumors If approved, ENHERTU would become the ...
Pharmabiz

EMA validates Daiichi Sankyo’s Enhertu type II variation application for patients with HER2 low or HER2 ultralow metastatic breast cancer

Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult ...
Pharmabiz

Pfizer, Astellas announce EMA validates type II variation application for Padcev with Keytruda for first-line treatment of advanced bladder cancer

Pfizer Inc. and Astellas Pharma Inc. announced that the European Medicines Agency (EMA) validated for review a type II variation application for Padcev (enfortumab vedotin) with Keytruda ...
AFP

ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 ...