89bio receives EMA PRIME status for pegozafermin in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis and compensated cirrhosis

27 March 2024 - PRIME status is supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin. ...

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Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia

26 March 2024 - Norgine today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...

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Highlights from the 18-21 March 2024 CHMP meeting

22 March 2024 - The EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting. ...

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Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA

22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...

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Astellas receives positive CHMP opinion for Xtandi in additional recurrent early prostate cancer treatment setting

22 March 2024 - If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk ...

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Outlook Therapeutics receives European Union positive CHMP opinion for ONS-5010 as a treatment for wet AMD

22 March 2024 - Positive opinion serves as a basis for final decision for potential authorisation from the European Commission ...

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Novartis Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria

22 March 2024 - Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior haemoglobin improvement in the ...

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Awiqli (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities

21 March 2024 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...

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UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa

22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I ...

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EMA publishes agenda for 18-21 March 2024 CHMP meeting

18 March 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma

6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...

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CymaBay announces EMA accepts for review the marketing authorisation application for seladelpar for the treatment of primary biliary cholangitis

5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...

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Madrigal Pharmaceuticals announces EMA validation of its marketing authorisation application for resmetirom for the treatment of NASH/MASH with liver fibrosis

5 March 2024 - MAA submission is supported by positive results from MAESTRO-NASH, the only Phase 3 trial in NASH to ...

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Two datopotamab deruxtecan applications validated in the EU for patients with advanced non-squamous non-small cell lung cancer or HR positive, HER2 negative breast cancer

4 March 2024 - Parallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase 3 trial results demonstrating Daiichi Sankyo and AstraZeneca’s ...

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SpringWorks Therapeutics announces EMA validation for marketing authorisation application of nirogacestat for the treatment of adults with desmoid tumours

29 February 2024 - Application based on Phase 3 DeFi trial in which nirogacestat significantly improved progression-free survival and objective response ...

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