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RSS FeedPosted by Michael Wonder on 31 Oct 2023
EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
31 October 2023 - The EMA’s CHMP has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant 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 26 Oct 2023
Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
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 ...
Posted by Michael Wonder on 24 Oct 2023
4DMT receives EMA Priority Medicines (PRIME) designation for 4D-150 clinical stage genetic medicine for treatment of wet AMD
23 October 2023 - 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four ...
Posted by Michael Wonder on 24 Oct 2023
Ipsen updates on EU marketing authorisation application for odevixibat in Alagille syndrome
23 October 2023 - Ipsen plans to submit a new marketing authorisation application for the treatment of Alagille syndrome by the ...
Posted by Michael Wonder on 23 Oct 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 mutant advanced non-small cell lung cancer
23 October 2023 - Approval based on DESTINY-Lung02 trial results where Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a confirmed objective ...
Posted by Michael Wonder on 21 Oct 2023
Rezolute receives Priority Medicines (PRIME) eligibility from EMA for enhanced regulatory support of RZ358 in congenital hyperinsulinism
17 October 2023 - PRIME eligibility granted based on key positive data from the Phase 2B (RIZE) study and current ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
16 October 2023 - Decision marks fifth approval for Keytruda in lung cancer in the EU. ...
Posted by Michael Wonder on 19 Oct 2023
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30 positive stage III Hodgkin lymphoma in combination with AVD
18 October 2023 - Approval based on updated positive overall survival results from the Phase 3 ECHELON-1 study for stage III ...
Posted by Michael Wonder on 18 Oct 2023
Merck receives positive EU CHMP opinion for Prevymis for prevention of CMV disease in high risk adult kidney transplant recipients and extended 200 day dosing in adult HSCT recipients at risk for late CMV infection and disease
17 October 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of Prevymis (letermovir) for ...