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RSS FeedPosted by Michael Wonder on 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
Posted by Michael Wonder on 16 Jun 2023
Takeda and HUTCHMED announce marketing authorisation application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
Posted by Michael Wonder on 23 May 2023
Pierre Fabre announces start of EU marketing authorization application procedure for vibegron in overactive bladder
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted by Michael Wonder on 11 May 2023
Servier receives European Commission approval of Tibsovo (ivosidenib tablets) in IDH1 mutated acute myeloid leukaemia and IDH1 mutated cholangiocarcinoma
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...
Posted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 26 Apr 2023
Celltrion seeks approval for Xolair biosimilar in EU
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
Posted by Michael Wonder on 26 Apr 2023
European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...
Posted by Michael Wonder on 21 Apr 2023
Incyte announces European Commission approval of Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents
20 April 2023 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improved facial and total body ...
Posted by Michael Wonder on 21 Apr 2023
GenSight Biologics withdraws its EMA application for Lumevoq
20 April 2023 - GenSight Biologics today announces that the Committee for Advanced Therapies (CAT) of the CHMP of the EMA ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 06 Apr 2023
Mirum submits for European approval of Livmarli in progressive familial intrahepatic cholestasis
5 April 2023 - Application based on statistically significant and clinically meaningful improvements in serum bile acids, pruritus, bilirubin, and growth ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...