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RSS FeedPosted by Michael Wonder on 30 Oct 2022
Pharming announces EMA validates its marketing authorisation application under accelerated assessment for leniolisib
28 October 2022 - Marketing authorisation in the European Economic Area anticipated in H1 2023 ...
Posted by Michael Wonder on 29 Oct 2022
Almirall announces EMA acceptance for filing of marketing authorisation application for lebrikizumab in atopic dermatitis
28 October 2022 - The EMA application is based on the analysis of Phase 3 studies ADvocate 1&2 and ADhere. ...
Posted by Michael Wonder on 28 Oct 2022
AbbVie announces submissions of regulatory applications for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory diffuse large B-cell lymphoma and large B-cell lymphoma
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...
Posted by Michael Wonder on 28 Oct 2022
European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV prevention
28 October 2022 - The marketing application is based on results from the HPTN 083 and 084 Phase 2b/3 studies ...
Posted by Michael Wonder on 11 Oct 2022
Pharming submits a marketing authorisation application to the European Medicines Agency for leniolisib
11 October 2022 - Application is based on randomised, controlled and long-term extension data for leniolisib as a treatment for ...
Posted by Michael Wonder on 04 Oct 2022
Santhera submits marketing authorisation application to the European Medicines Agency for vamorolone in Duchenne muscular dystrophy
3 October 2022 - Santhera Pharmaceuticals announces that the Company has submitted a marketing authorisation application to the EMA for ...
Posted 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. ...