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RSS FeedPosted by Michael Wonder on 31 Mar 2021
VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the marketing authorisation application for difelikefalin
30 March 2021 - Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics today announced that the EMA accepted to ...
Posted 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
Amryt announces validation of its MAA by the EMA for Oleogel-S10 (Filsuvez)
29 March 2021 - Amryt today announces the validation of the Company’s marketing authorisation application for Oleogel-S10 by the EMA for ...
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 29 Mar 2021
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-L201 gene therapy for treatment of leukocyte adhesion deficiency-I
29 March 2021 - LAD-I program now holds all available accelerated regulatory designations in the U.S. and EU. ...
Posted by Michael Wonder on 29 Mar 2021
Saxenda recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years
26 March 2021 - Novo Nordisk today announced that the CHMP under the EMA has recommended that the use of Saxenda ...
Posted by Michael Wonder on 29 Mar 2021
GSK receives CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis
26 March 2021 - GlaxoSmithKline today announced the CHMP of the EMA has adopted a positive opinion recommending the use of ...
Posted by Michael Wonder on 29 Mar 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis with at least one F508del mutation
26 March 2021 - If approved, people ages 12 years and older who have one copy of the F508del mutation and ...
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
Highlights from the CHMP 22-25 March 2022 meeting
26 March 2021 - EMA’s CHMP recommended five medicines for approval at its March 2021 meeting. ...
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. ...