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RSS FeedPosted by Michael Wonder on 29 Jun 2020
Daiichi Sankyo provides update on CHMP review of pexidartinib, a CSF1R inhibitor for the treatment of patients with TGCT
26 June 2020 - Daiichi Sankyo today announced that the Committee for Medicinal Products for Human Use of the European Medicines ...
Posted by Michael Wonder on 28 Jun 2020
ERC Belgium submits marketing authorisation application to European Medicines Agency for glioblastoma immunotherapy, Sitoiganap
26 June 2020 - ERC Belgium has announced that it has submitted to the EMA its marketing authorisation application for ...
Posted by Michael Wonder on 28 Jun 2020
Novartis pulls dry eye drug Xiidra's bid for approval in Europe
27 June 2020 - Swiss drugmaker Novartis has withdrawn an application for European approval of its Xiidra dry eye medicine ...
Posted by Michael Wonder on 22 Jun 2020
European Medicines Agency validates application for Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
22 June 2020 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation ...
Posted by Michael Wonder on 19 Jun 2020
Cancer Prevention Pharmaceuticals submits EU marketing authorisation application for CPP-1X/sul for treatment of familial adenomatous polyposis
18 June 2020 - Cancer Prevention Pharmaceuticals announced today that it has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 19 Jun 2020
BeiGene announces European Medicines Agency acceptance of its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinaemia
18 June 2020 - BeiGene today announced that its marketing authorisation application for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted by Michael Wonder on 11 Jun 2020
LEO Pharma announces European Medicines Agency acceptance of marketing authorisation application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
11 June 2020 - LEO Pharma today announced that the European Medicines Agency validated the marketing authorization application for tralokinumab, an ...
Posted by Michael Wonder on 08 Jun 2020
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for ...
Posted by Michael Wonder on 07 Jun 2020
Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure
5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
Posted by Michael Wonder on 01 Jun 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis
1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...
Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for ...
Posted by Michael Wonder on 23 May 2020
Intercept provides regulatory update
22 May 2020 - Intercept Pharmaceuticals today announced that based on discussions earlier this week, the U.S. FDA has notified Intercept ...
Posted by Michael Wonder on 22 May 2020
EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486
22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 ...
Posted by Michael Wonder on 22 May 2020
European Medicines Agency accepts Astellas’ marketing authorisation application for roxadustat
21 May 2020 - Submission for the treatment of anaemia in adult patients with chronic kidney disease. ...
Posted by Michael Wonder on 21 May 2020
Incyte and MorphoSys announce the validation of the European marketing authorisation application for tafasitamab
20 May 2020 - The application seeks approval of tafasitamab in combination with lenalidomide for the treatment of adult patients with ...