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RSS FeedPosted by Michael Wonder on 25 Apr 2024
Travere Therapeutics and CSL Vifor announce European Commission approves Filspari (sparsentan) for the treatment of IgA nephropathy
24 April 2024 - Conditional marketing authorisation is based on statistically significant and clinically meaningful results from the Phase 3 ...
Posted by Michael Wonder on 24 Apr 2024
Averoa submits marketing authorisation application to the European Medicines Agency seeking approval of AVA1014 for treating complications associated with chronic kidney disease
23 April 2024 - Averoa announces the submission of a marketing authorisation application to the EMA for Ferric Citrate Coordination ...
Posted by Michael Wonder on 23 Apr 2024
Astellas' Xtandi (enzalutamide) granted European Commission approval for use in additional recurrent early prostate cancer treatment setting
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
Posted by Michael Wonder on 23 Apr 2024
Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia
23 April 2024 - ALPHA Phase 3 trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris ...
Posted by Michael Wonder on 23 Apr 2024
New recommendations to strengthen supply chains of critical medicines
23 April 2024 - EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines ...
Posted by Michael Wonder on 23 Apr 2024
European Commission approves Pfizer’s Emblaveo for patients with multidrug-resistant infections and limited treatment options
22 April 2024 - Emblaveo was reviewed under EMA accelerated assessment procedure, used when a pharmaceutical product is of major ...
Posted by Michael Wonder on 22 Apr 2024
Carvykti (ciltacabtagene autoleucel) is the first BCMA targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
Posted by Michael Wonder on 22 Apr 2024
EMA publishes agenda for 22-25 April 2024 CHMP meeting
22 April 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 22 Apr 2024
UCB receives European Commission approval for Bimzelx (bimekizumab) as the first IL-17A and IL-17F biologic for moderate to severe hidradenitis suppurativa
22 April 2024 - Approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 18 Apr 2024
COVID-19 vaccine strain updates: global regulators agree on timing and data requirements
17 April 2024 - International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...
Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval ...
Posted by Michael Wonder on 04 Apr 2024
Rocket Pharmaceuticals announces EMA acceptance of RP-L102 marketing authorisation application for the treatment of Fanconi anaemia
2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...
Posted by Michael Wonder on 03 Apr 2024
European Commission expands approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to include first-line treatment of transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...