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RSS FeedPosted by Michael Wonder on 04 May 2021
Astellas' Xtandi (enzalutamide) approved by European Commission for men with metastatic hormone sensitive prostate cancer
4 May 2021 - Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types ...
Posted by Michael Wonder on 01 May 2021
Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...
Posted by Michael Wonder on 28 Apr 2021
Y-mAbs submits omburtamab marketing authorisation application to the EMA
27 April 2021 - Y-mAbs Therapeutics today announced that the Company has submitted its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 27 Apr 2021
Karyopharm announces European Medicines Agency's validation of its type II variation marketing authorisation application for Nexpovio (selinexor) in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma
26 April 2021 - EMA regulatory decision expected in the fourth quarter of 2021. ...
Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
Posted by Michael Wonder on 26 Apr 2021
Tagrisso recommended for approval in the EU by CHMP for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
26 April 2021 - Opinion based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk of ...
Posted by Michael Wonder on 26 Apr 2021
European Commission approves GSK’s Jemperli (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer
23 April 2021 - The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for unresectable malignant pleural mesothelioma
23 April 2021 - Recommendation based on positive results from the Phase 3 CheckMate-743 trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 26 Apr 2021
Bristol Myers Squibb receives positive CHMP opinion for Onureg (azacitidine tablets; CC-486) as frontline oral maintenance therapy for adults with acute myeloid leukaemia in first remission
23 April 2021 - In the pivotal Quazar AML-001 study, Onureg demonstrated significant overall survival and showed a relapse-free survival benefit ...
Posted by Michael Wonder on 25 Apr 2021
AbbVie receives positive CHMP opinion for Venclyxto (venetoclax) as a combination regimen for adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
23 April 2021 - Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and ...
Posted by Michael Wonder on 17 Apr 2021
Oncopeptides submits application for conditional marketing authorisation of melflufen in the EU
16 April 2021 - Oncopeptides today announces that the Company has submitted an application to the EMA for conditional marketing authorisation ...
Posted by Michael Wonder on 15 Apr 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma
14 April 2021 - Approval based on Phase 3 CheckMate-9ER trial results showing Opdivo in combination with Cabometyx significantly improved overall ...
Posted by Michael Wonder on 05 Apr 2021
Copikta (duvelisib) receives positive CHMP opinion for the treatment of relapsed and refractory CLL and refractory FL
1 April 2021 - Secura Bio announced that the CHMP of the EMA adopted a positive opinion recommending the approval of ...
Posted by Michael Wonder on 01 Apr 2021
European Commission approves Cabometyx in combination with Opdivo as a first-line treatment for patients living with advanced renal cell carcinoma
31 March 2021 - Approval based on pivotal Phase 3 CheckMate-9ER trial data, also recently published in the New England Journal ...
Posted by Michael Wonder on 31 Mar 2021
Merck receives positive EU CHMP opinion for updated label of Keytruda (pembrolizumab) to include results of Phase 3 KEYNOTE-361 trial in certain adult patients with locally advanced or metastatic urothelial cancer
30 March 2021 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending that the ...