Blog
RSS FeedPosted by Michael Wonder on 14 Jul 2023
European Medicines Agency accepts Astellas' marketing authorisation application for zolbetuximab
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...
Posted by Michael Wonder on 11 Jul 2023
European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
11 July 2023 - Approval is based on results from the Phase I/II NP30179 study, where Columvi given as a fixed ...
Posted by Michael Wonder on 05 Jul 2023
European Commission grants conditional marketing authorisation for Taiho's Lytgobi tablets for the treatment of adults with cholangiocarcinoma
4 July 2023 - Lytgobi is the first irreversibly binding FGFR inhibitor in the European Union for use in the ...
Posted by Michael Wonder on 30 Jun 2023
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
29 June 2023 - Approval based on results from Phase 3 CheckMate-816 trial showing that neo-adjuvant Opdivo with chemotherapy improved ...
Posted by Michael Wonder on 26 Jun 2023
Gilead receives CHMP positive opinion for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer
23 June 2023 - Recommendation based on the TROPiCS-02 study showing Trodelvy demonstrated statistically significant and clinically meaningful overall survival in ...
Posted by Michael Wonder on 16 Jun 2023
Takeda and HUTCHMED announce marketing authorisation application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
Posted by Michael Wonder on 10 Jun 2023
A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the EMA (2017-2021)
9 June 2023 - A review of new oncology indications approved by the EMA for 2012-2016 showed that 33% of new ...
Posted by Michael Wonder on 05 Jun 2023
TG Therapeutics announces European Commission approval for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
1 June 2023 - TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the European Commission (EC) has granted approval of ...
Posted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 11 May 2023
Servier receives European Commission approval of Tibsovo (ivosidenib tablets) in IDH1 mutated acute myeloid leukaemia and IDH1 mutated cholangiocarcinoma
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...
Posted by Michael Wonder on 04 May 2023
Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
3 May 2023 - Approval of Breyanzi based on the pivotal Phase 3 TRANSFORM trial, in which Breyanzi significantly improved ...
Posted by Michael Wonder on 28 Apr 2023
CHMP issues positive opinion for futibatinib for the treatment of adults with cholangiocarcinoma
27 April 2023 - Taiho Pharmaceutical announced today that the EMA's CHMP has issued a positive opinion recommending the conditional ...
Posted by Michael Wonder on 27 Apr 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
26 April 2023 - The recommendation is based on results from the Phase I/II NP30179 study, where Columvi given as a ...
Posted by Michael Wonder on 26 Apr 2023
European Medicines Agency validates marketing authorisation application for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...