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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
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 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 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 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 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 ...
Posted by Michael Wonder on 17 Oct 2023
GSK receives positive CHMP opinion recommending approval of Jemperli (dostarlimab) plus chemotherapy as a new frontline treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
16 October 2023 - If approved, dostarlimab would become the first new frontline treatment option in the European Union in ...
Posted by Michael Wonder on 16 Oct 2023
Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of invasive candidiasis in adults
13 October 2023 - The opinion was based on positive results from the pivotal ReSTORE Phase 3 clinical trial and supported ...
Posted by Michael Wonder on 16 Oct 2023
Santhera receives positive CHMP opinion recommending approval of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy
13 October 2023 - Agamree could become the first drug fully approved by the EMA for the treatment of patients with Duchenne ...
Posted by Michael Wonder on 16 Oct 2023
EU delays approval of Novavax's revised COVID vaccine
16 October 2023 - European Union regulators have delayed a decision to give approval for Novavax's variant-tailored COVID-19 vaccine, the ...
Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
Posted by Michael Wonder on 13 Oct 2023
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) in relapsed or refractory follicular lymphoma
13 October 2023 - If approved, Brukinsa will be the first and only BTK inhibitor approved for follicular lymphoma. ...
Posted by Michael Wonder on 13 Oct 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for HER2 negative advanced gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)
13 October 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial. ...