30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
30 September 2022 - If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor ...
28 September 2022 - Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 ...
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
14 September 2022 - 4, 2022 - Minoryx Therapeutics today announces that it has filed a marketing authorisation application for its ...
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
9 September 2022 - Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo. ...
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
30 August 2022 - The information is somewhat buried on the EMA website. ...
26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July. ...
24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...