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RSS FeedPosted by Michael Wonder on 18 Sep 2023
BioMarin receives positive CHMP opinion in Europe to expand use of Voxzogo (vosoritide) to treat children aged 4 months and older with achondroplasia
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
Posted by Michael Wonder on 13 Sep 2023
European Medicines Agency validates type II variation for Astellas' Xtandi (enzalutamide) for treatment of non-metastatic hormone sensitive prostate cancer with high risk biochemical recurrence
13 September 2023 - Application based on results from Phase 3 EMBARK trial, which showed Xtandi plus leuprolide reduced risk ...
Posted by Michael Wonder on 09 Sep 2023
Janssen submits marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations
8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in ...
Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was ...
Posted by Michael Wonder on 06 Sep 2023
Italfarmaco Group receives EMA validation of marketing authorisation application for givinostat in Duchenne muscular dystrophy
5 September 2023 - Italfarmaco Group announced today that its marketing authorisation application for givinostat as a potential treatment for ...
Posted by Michael Wonder on 06 Sep 2023
Arcturus Therapeutics and CSL announce European Medicines Agency validates marketing authorisation application for ARCT-154 vaccine to prevent COVID-19
5 September 2023 - EMA application supported by Phase 3 primary vaccination study demonstrating primary efficacy endpoint was met. ...
Posted by Michael Wonder on 31 Aug 2023
InflaRx’s marketing authorisation application for vilobelimab for treatment of critically ill COVID-19 patients under review by European Medicines Agency
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical ...
Posted by Michael Wonder on 25 Aug 2023
European Medicines Agency accepts Novaliq’s marketing authorisation application for CyclASol (cyclosporin ophthalmic solution) 0.1% for the treatment of dry eye disease
24 August 2023 - Novaliq today announced that the EMA has accepted the marketing authorisation application for CyclASol (ciclosporin ophthalmic ...
Posted by Michael Wonder on 19 Aug 2023
EMA accepts Leo Pharma’s marketing authorisation application for delgocitinib cream in chronic hand eczema
18 August 2023 - Leo Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, ...
Posted by Michael Wonder on 17 Aug 2023
European Medicines Agency accepts Iveric Bio’s marketing authorisation application for avacincaptad pegol for geographic atrophy
18 August 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the marketing authorisation application for ...
Posted by Michael Wonder on 17 Aug 2023
Odronextamab receives EMA filing acceptance for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma
17 August 2023 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for odronextamab ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 18 Jul 2023
Roche withdraws type II variation for Gazyvaro
18 July 2023 - The EMA has published the letter from Roche on its website. ...
Posted by Michael Wonder on 18 Jul 2023
UCB announces EU regulatory filing for bimekizumab for the treatment of moderate to severe hidradenitis suppurativa
18 July 2023 - Regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa. ...