European Commission approves Merck’s Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer at high risk of recurrence in adults

28 March 2024 - Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung ...

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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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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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Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) becomes first CAR T cell therapy approved in the European Union in earlier lines for triple-class exposed relapsed and refractory multiple myeloma

20 March 2024 - Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in ...

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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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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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