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RSS FeedPosted by Michael Wonder on 25 Aug 2022
Janssen marks first approval worldwide for Tecvayli (teclistamab) with EC authorisation of first in class bispecific antibody for the treatment of patients with multiple myeloma
24 August 2022 - Teclistamab, an off the shelf subcutaneously administered therapy, induced deep and rapid responses in triple class ...
Posted by Michael Wonder on 25 Aug 2022
First gene therapy for adults with severe haemophilia A, BioMarin's Roctavian (valoctocogene roxaparvovec), approved by European Commission
24 August 2022 - Maintains orphan drug designation in the EU providing 10 years of market exclusivity. ...
Posted by Michael Wonder on 22 Aug 2022
Gilead announces first global regulatory approval of Sunlenca (lenacapavir), the only twice yearly HIV treatment option
22 August 2022 - European Commission grants marketing authorisation for Sunlenca, helping to address a critical unmet clinical need for ...
Posted by Michael Wonder on 22 Aug 2022
Kyowa Kirin receives European Commission approval for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
19 August 2022 - Crysvita is the first approved biologic treatment in the EU for patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 20 Aug 2022
European Commission approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer
18 August 2022 - Vegzelma offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical ...
Posted by Michael Wonder on 19 Aug 2022
European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
18 August 2022 - Oncopeptides today announces that the European Commission has granted Pepaxti (melphalan flufenamide) marketing authorisation in combination ...
Posted by Michael Wonder on 15 Aug 2022
argenx announces European Commission approval of Vyvgart (efgartigimod alfa-fcab) for the treatment of generalised myasthenia gravis
11 August 2022 - Vyvgart is the first neonatal Fc receptor blocker approved in Europe for the treatment of adults living ...
Posted by Michael Wonder on 11 Aug 2022
European Commission approves Imbruvica (ibrutinib) fixed duration combination for adult patients with previously untreated chronic lymphocytic leukaemia
9 August 2022 - It is the first all oral, fixed duration, once daily treatment based on a Bruton's tyrosine kinase ...
Posted by Michael Wonder on 04 Aug 2022
Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer
4 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...
Posted by Michael Wonder on 29 Jul 2022
Rinvoq (upadacitinib) approved by European Commission as an oral treatment for adults with active non-radiographic axial spondyloarthritis
29 July 2022 - Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which ...
Posted by Michael Wonder on 26 Jul 2022
LFB announces the approval of Cevenfacta (eptacog beta) in the European Union
25 July 2022 - The first new bypassing agent approved in the European Union for the treatment and control of bleeding ...
Posted by Michael Wonder on 26 Jul 2022
European Commission approves Rinvoq (upadacitinib) for the treatment of adults with moderate to severe ulcerative colitis
26 July 2022 - The approval is based on the results of three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 25 Jul 2022
BridgeBio Pharma and Sentynl Therapeutics receive positive CHMP opinion for Nulibry (fosdenopterin) for the treatment of MoCD type A
25 July 2022 - CHMP recommendation for approval of Nulibry in the European Union for the treatment of patients with molybdenum ...
Posted by Michael Wonder on 25 Jul 2022
Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma
25 July 2022 - First and only biologic recommended for EU approval in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 25 Jul 2022
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis
25 July 2022 - First and only long-acting C5 complement inhibitor showed early effect and demonstrated clinical improvement in activities ...