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RSS FeedPosted by Michael Wonder on 10 Nov 2023
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
Posted by Michael Wonder on 09 Nov 2023
Getting ready for EMA’s website relaunch on 5 December 2023
9 November 2023 - The EMA is relaunching its corporate website on 5 December 2023. ...
Posted by Michael Wonder on 09 Nov 2023
Vanflyta approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML
9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...
Posted by Michael Wonder on 08 Nov 2023
First electronic product information published for selected human medicines
8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 07 Nov 2023
Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040
6 November 2023 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is publishing new research which assesses the ...
Posted by Michael Wonder on 06 Nov 2023
EMA publishes agenda for 6-9 November 2023 CHMP meeting
6 November 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 03 Nov 2023
EC approves Ryeqo for the symptomatic treatment of endometriosis
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
Posted by Michael Wonder on 03 Nov 2023
European Medicines Agency validates Pierre Fabre Laboratories' marketing authorisation application for combination Braftovi (encorafenib) and Mektovi (binimetinib) for patients with BRAF V600 mutant advanced non-small cell lung cancer
2 November 2023 - The application is based on results from the PHAROS study, which showed an objective response rate of ...
Posted by Michael Wonder on 30 Oct 2023
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment ...
Posted by Michael Wonder on 30 Oct 2023
Egetis announces EMA validation of marketing authorisation application for Emcitate for the treatment of MCT8 deficiency
27 October 2023 - Egetis Therapeutics today announced that its marketing authorisation application to the EMA for Emcitate (tiratricol) for ...
Posted by Michael Wonder on 28 Oct 2023
ImmunoGen announces European Medicines Agency acceptance of marketing authorisation application for mirvetuximab soravtansine in platinum-resistant ovarian cancer
27 October 2023 - ImmunoGen today announced that the EMA has accepted the marketing authorisation application for mirvetuximab soravtansine (Elahere) ...
Posted by Michael Wonder on 25 Oct 2023
Orphelia Pharma files EU marketing authorisation application for Kizfizo
24 October 2023 - Orphelia Pharma today announces the filing of a centralised marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 25 Oct 2023
Annexon receives PRIME designation from the EMA for ANX007 for the treatment of geographic atrophy
24 October 2023 - PRIME designation granted based on Phase 2 ARCHER trial results, which showed meaningful preservation of visual function ...
Posted by Michael Wonder on 24 Oct 2023
EMA takes further steps to address critical shortages of medicines in the EU
24 October 2023 - Today, the EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages ...