IntraBio Announces Submission of Variation Application to the European Medicines Agency for AQNEURSA® for Ataxia-Telangiectasia

IntraBio Inc. today announced the submission of a variation application to the European Medicines Agency (EMA) to expand the approved Marketing Authorization Application (MAA) for AQNEURSA® ...
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 ...

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Business Wire

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Low Metastatic Breast Cancer with HR Positive and HR Negative Disease

TOKYO & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as ...
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 ...