(IN BRIEF) In early 2024, Europe's medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like…
(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by…
(IN BRIEF) The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have jointly released a comprehensive Artificial…
(IN BRIEF) Pfizer and BioNTech have received a recommendation for marketing authorization from the European Medicines Agency's Committee for Medicinal…
(PRESS RELEASE) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), a British-Swedish multinational pharmaceutical and biotechnology company, has announced that…
(COMUNICADO DE PRENSA) CAMBRIDGE, 13-Jan-2023 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), una multinacional británica-sueco-farmacéutica y biotecnológica, ha anunciado que su…
Zulassungsantrag für die Behandlung von Anämie bei chronischer Nierenerkrankung basierend auf dem klinischen Phase-III-Studienprogramm ASCEND, bestehend aus fünf Studien, die…
Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting…
New arrangement leverages Kuehne+Nagel’s global solutions for pharma & healthcare logistics (PRESS RELEASE) CAMBRIDGE, MA, U.S.A. / SCHINDELLEGI, 7-Jan-2021 —…
(PRESS RELEASE) VALBY, Denmark, 22-Dec-2020 — /EuropaWire/ — Danish international pharmaceutical company, H. Lundbeck A/S (Lundbeck) announces that its marketing…
(PRESS RELEASE) GENEVA, 26-Mar-2020 — /EuropaWire/ — Inspection, verification, testing and certification company SGS announced it has developed a test…
(PRESS RELEASE) AMSTERDAM, 16-Jan-2020 — /EuropaWire/ — The European Medicines Agency (EMA) appoints Dr Hilmar Hamann as Head of the…
EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA)…
(PRESS RELEASE) LONDON, 27-Mar-2019 — /EuropaWire/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird…
Fresh design and improved features to provide better user experience LONDON, 25-Sep-2018 — /EuropaWire/ — The European Medicines Agency (EMA) will…
Publication of updated Q+As and practical guidance LONDON, 20-Jun-2018 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission…
Workshop with regulators from EU, Japan and US open for registration LONDON, 28-May-2018 — /EuropaWire/ — The European Medicines Agency (EMA),…
Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and…
Close collaboration with new host country as of day one key for successful move LONDON, 09-Nov-2017 — /EuropaWire/ — With less…
LONDON, 10-Oct-2017 — /EuropaWire/ — The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal…
European Medicines Agency and healthcare payer organisations held joint meeting on 19 September LONDON, 29-Sep-2017 — /EuropaWire/ — The European Medicines…
BRUSSELS, 03-Aug-2017 — /EuropaWire/ — The application procedure to host the two UK-based EU agencies, the European Medicines Agency (EMA) and…
The European Medicines Agency (EMA) is currently looking for a new location in connection with the UK’s withdrawal from the…
LONDON, 03-Apr-2017 — /EuropaWire/ — As a science-driven organisation, the European Medicines Agency (EMA) has developed a framework to formalise,…
EMA workshop will discuss role of patients, consumers and healthcare professionals LONDON, 07-Mar-2017 — /EuropaWire/ — How has the concept of…
OCREVUS is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis (MS) FDA grants…
EMA veterinary committee sets objectives to limit risks arising from use of antimicrobials in animals LONDON, 20-11-2015 — /EuropaWire/ —…
Deadline to submit expressions of interest to represent civil society at PRAC andCAT to European Commission extended until 18 October…
EMA publishes workshop report on requirements for the authorisation of vaccines LONDON, 14-7-2015 — /EuropaWire/ — The European Medicines Agency…
Registration now open for a workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) on…
LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to…
29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that…
30-7-2013 — /EuropaWire/ — The European Medicines Agency (EMA) has published the ‘First annual report onEudraVigilance for the European Parliament, the Council…
23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range…