MAESTrO: Blog

Posted by Michael Wonder on 22 Jul 2023

Merck receives positive European Union CHMP opinion for gefapixant

21 July 2023 - Merck today announced that the CHMP of the EMA has recommended the approval of gefapixant, an investigational, ...

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Posted by Michael Wonder on 21 Jul 2023

AbbVie receives positive CHMP opinion for epcoritamab (Tepkinly) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma

21 July 2023 - The positive CHMP opinion is supported by results from the EPCORE NHL-1 Phase 1/2 trial evaluating the ...

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Posted by Michael Wonder on 20 Jul 2023

Ipsen announces European Commission decision on palovarotene for the treatment of FOP

19 July 2023 - European Commission determines not to grant marketing authorisation approval for palovarotene for fibrodysplasia ossificans progressiva. ...

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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 ...

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Posted by Michael Wonder on 05 Jul 2023

European Commission approves Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis ages 1 to 2 years old

5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...

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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 ...

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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 ...

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Posted by Michael Wonder on 29 Jun 2023

Amicus Therapeutics announces approval and launch of new Pompe disease therapy in the European Union

27 June 2023 - Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat) now approved in the European Union for adults with late-onset Pompe ...

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Posted by Michael Wonder on 26 Jun 2023

GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis

26 June 2023 - GSK today announced that the CHMP of the EMA has issued a positive opinion recommending authorisation ...

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Posted by Michael Wonder on 26 Jun 2023

Soliris recommended for approval in the EU by CHMP for children and adolescents with refractory generalised myasthenia gravis

26 June 2023 - The first in class C5 inhibitor reduced disease severity and symptoms with sustained improvements over 26 ...

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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 ...

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