18 July 2022 - The submission is based on two pivotal Phase 3 studies evaluating atogepant in adult patients with episodic ...
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
20 June 2022 - Application based on Phase 3 TRANSFORM study in which Breyanzi outperformed the current standard of care ...
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
15 June 2022 - EMA has started a rolling review for a version of Comirnaty adapted to provide better protection ...
7 June 2022 - Sifi has launched an early access program across European countries in June 2022. ...
19 May 2022 - Submission follows the U.S. FDA acceptance of the adagrasib new drug application for the same indication ...
19 May 2022 - 2022 – Valneva today confirmed that the EMA has accepted the filing of a marketing authorisation ...
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib ...
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for ...
6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and ...