Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion as the first and only therapy for indolent systemic mastocytosis

10 November 2023 - Opinion based on the positive PIONEER trial, in which once daily Ayvakyt achieved significant improvements across ...

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Mirati Therapeutics receives positive opinion from CHMP for Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small cell lung cancer with a KRAS G12C mutation following a re-examination procedure

10 November 2023 - Mirati Therapeutics today announced that following a re-examination procedure, the Company has received a positive opinion ...

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UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalised myasthenia gravis in Europe

10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis ...

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STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara

10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...

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Getting ready for EMA’s website relaunch on 5 December 2023

9 November 2023 - The EMA is relaunching its corporate website on 5 December 2023. ...

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Vanflyta approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML

9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...

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First electronic product information published for selected human medicines

8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...

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Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)

7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...

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Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040

6 November 2023 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is publishing new research which assesses the ...

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EMA publishes agenda for 6-9 November 2023 CHMP meeting

6 November 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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EC approves Ryeqo for the symptomatic treatment of endometriosis

2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...

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European Medicines Agency validates Pierre Fabre Laboratories' marketing authorisation application for combination Braftovi (encorafenib) and Mektovi (binimetinib) for patients with BRAF V600 mutant advanced non-small cell lung cancer

2 November 2023 - The application is based on results from the PHAROS study, which showed an objective response rate of ...

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EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5

31 October 2023 - The EMA’s CHMP has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of ...

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European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma

30 October 2023 - If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for the first-line treatment ...

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Egetis announces EMA validation of marketing authorisation application for Emcitate for the treatment of MCT8 deficiency

27 October 2023 - Egetis Therapeutics today announced that its marketing authorisation application to the EMA for Emcitate (tiratricol) for ...

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