(IN BRIEF) EMA proposes Comirnaty Omicron XBB.1.5 vaccine for ages 6 months+, tailored to combat Omicron XBB.1.5 variant. One dose…
Not intended for U.S. and UK Media (IN BRIEF) The European Medicines Agency's Committee for Medicinal Products for Human Use…
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) VEVEY, 14-Oct-2020 — /EuropaWire/ — Nestlé has successfully closed the acquisition of biopharmaceutical company, Aimmune Therapeutics, Inc. (Nasdaq:…
(PRESS RELEASE) BERLIN, 14-Aug-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have…
EMA, MHRA and FDA among regulatory agencies participating (PRESS RELEASE) BERLIN, 10-Jun-2019 — /EuropaWire/ — The Parenteral Drug Association (PDA)…
Fresh design and improved features to provide better user experience LONDON, 25-Sep-2018 — /EuropaWire/ — The European Medicines Agency (EMA) will…
Medicine to be voluntarily withdrawn from the market by the company LONDON, 06-Mar-2018 — /EuropaWire/ — The European Medicines Agency (EMA)…
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…
LONDON, 03-Apr-2017 — /EuropaWire/ — As a science-driven organisation, the European Medicines Agency (EMA) has developed a framework to formalise,…
Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for…
LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European…
Companies encouraged to submit expressions of interest LONDON, 23-4-2015 — /EuropaWire/ — The deadline for submitting expressions of interest to…
LONDON, 13-11-2014 — /EuropaWire/ — GSK today announced the submission to the European Medicines Agency (EMA) of a variation to…
EMA to allow use of non-EEA authorised comparator in clinical studies; new guidance applicable as of today LONDON, 30-10-2014 —…
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…
16-8-2013 — /EuropaWire/ — The European Medicines Agency has published a reflection paper on general issues for consideration regarding the parenteral administration of…
12-7-2013 — /europawire.eu/ — The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web client to…
26-6-2013 — /europawire.eu/ — The European Medicines Agency has released a draft policy on the publication and access to clinical-trial data…
23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range…
London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to…