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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European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...

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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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Added benefit and revenues of oncology drugs approved by the EMA between 1995 and 2020: retrospective cohort study

28 February 2024 - Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the US, ...

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BeiGene receives positive CHMP opinion for tislelizumab as treatment for non-small-cell lung cancer

26 February 2024 - Recommendation based on results of three Phase 3 clinical trials demonstrating benefit of tislelizumab as a first- ...

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Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia

26 February 2024 - Recommendation of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial results. ...

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CSL Vifor and Travere Therapeutics announce sparsentan receives positive CHMP opinion for the treatment of IgA nephropathy

23 February 2024 - Positive CHMP opinion is based on pivotal Phase 3 PROTECT study results. ...

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Highlights from the 19-22 February 2024 CHMP meeting

23 February 2024 - The EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting. ...

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Vertex receives CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older

23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...

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Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma

23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...

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First oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria

23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first ...

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