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RSS FeedPosted by Michael Wonder on 30 Mar 2021
EMA accepts the marketing authorisation applications for two additional indications of anti-cancer agent lenvatinib in combination with pembrolizumab as a treatment for advanced renal cell carcinoma and advanced endometrial carcinoma
30 March 2021 - Eisai announced today that the EMA has confirmed it has accepted for review applications for the use ...
Posted by Michael Wonder on 30 Mar 2021
Incyte announces the European Commission approval of Pemazyre (pemigatinib) as a treatment for adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement
29 March 2021 - Pemazyre is the first targeted therapy approved in the European Union for this indication. ...
Posted by Michael Wonder on 30 Mar 2021
Karyopharm receives conditional marketing authorisation from the European Commission for Nexpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed and or refractory multiple myeloma
29 March 2021 - Second European Regulatory Filing Based on Phase 3 BOSTON Data Expected by April 2021. ...
Posted by Michael Wonder on 30 Mar 2021
Myovant Sciences announces European Medicines Agency validation of marketing authorisation application for relugolix for the treatment of advanced prostate cancer
29 March 2021 - Pfizer has an exclusive option to commercialise relugolix in oncology outside of the U.S. and Canada, ...
Posted by Michael Wonder on 29 Mar 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
29 March 2021 - If approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in ...
Posted by Michael Wonder on 28 Mar 2021
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for patients with metastatic hormone-sensitive prostate cancer
26 March 2021 - If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of ...
Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial ...
Posted by Michael Wonder on 26 Mar 2021
EMA validates marketing authorisation application for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer
25 March 2021 - Agency grants accelerated assessment based on positive results of Phase 3 ASCENT trial. ...
Posted by Michael Wonder on 17 Mar 2021
European Commission approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult and paediatric patients with relapsed or refractory classical Hodgkin lymphoma
17 March 2021 - First Pediatric Indication for KEYTRUDA in the European Union. ...
Posted by Michael Wonder on 09 Mar 2021
Sesen Bio submits marketing authorisation application to the European Medicines Agency for Vicineum
8 March 2021 - Potential approval in Europe anticipated in early 2022. ...
Posted by Michael Wonder on 04 Mar 2021
Blueprint Medicines announces EMA validation of type II variation marketing authorisation application for Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
Posted by Michael Wonder on 01 Mar 2021
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for retifanlimab as a treatment for patients with squamous cell anal carcinoma
26 February 2021 - Incyte today announced the validation of the Company’s marketing authorisation application for retifanlimab, an intravenous PD-1 ...
Posted by Michael Wonder on 28 Feb 2021
GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer
26 February 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending dostarlimab, an anti-programmed ...
Posted by Michael Wonder on 14 Feb 2021
European Commission approves Seagen’s Tukysa (tucatinib) for the treatment of patients with locally advanced or metastatic HER2 positive breast cancer
12 February 2021 - Approved for adult patients with HER2 positive metastatic breast cancer who have received at least two prior ...
Posted by Michael Wonder on 09 Feb 2021
Bristol Myers Squibb receives European Commission approval for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
8 February 2021 - Inrebic, a once-daily, oral therapy, is the first new treatment option approved in Europe for myelofibrosis in ...