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RSS FeedPosted by Michael Wonder on 30 Sep 2022
Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)
30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...
Posted by Michael Wonder on 30 Sep 2022
European Medicines Agency accepts Astellas’ marketing authorisation application for fezolinetant
30 September 2022 - If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor ...
Posted by Michael Wonder on 29 Sep 2022
European Medicines Agency accepts Moderna's conditional marketing authorisation filing for its Omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
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 ...
Posted by Michael Wonder on 20 Sep 2022
EMA accepts MediWound’s application for extended indication for NexoBrid to treat paediatric patients with severe thermal burns
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
Posted by Michael Wonder on 20 Sep 2022
European Medicine Agency accepts marketing authorisation applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...
Posted by Michael Wonder on 16 Sep 2022
Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
Posted by Michael Wonder on 14 Sep 2022
Minoryx‘s marketing authorisation application for its lead candidate leriglitazone validated by EMA for orphan indication X-linked adrenoleukodystrophy
14 September 2022 - 4, 2022 - Minoryx Therapeutics today announces that it has filed a marketing authorisation application for its ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 09 Sep 2022
FDA and EMA accept regulatory submission for Pfizer’s ritlecitinib for individuals 12 years and older with alopecia areata
9 September 2022 - Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo. ...
Posted by Michael Wonder on 07 Sep 2022
EMA refused rolling review of SK Bioscience's COVID-19 vaccine
7 September 2022 - The EMA refused a rolling review of SK Bioscience's COVID-19 vaccine, SKYCovine, due to “changing pandemic ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 30 Aug 2022
EMA announces withdrawal of two submissions for cancer medicines
30 August 2022 - The information is somewhat buried on the EMA website. ...
Posted by Michael Wonder on 27 Aug 2022
Pfizer and BioNTech complete submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July. ...
Posted by Michael Wonder on 25 Aug 2022
AB Science announces that it has filed an application for conditional marketing authorisation to EMA for masitinib in the treatment of ALS
24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...