EMA agrees to review UCB's bimekizumab

18 August 2020 - Information about marketing authorisation application to EMA not yet disclosed by UCB. ...

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Seqirus announces positive CHMP Opinion for its adjuvanted quadrivalent influenza vaccine

31 March 2020 - Seqirus today announced that its adjuvanted quadrivalent influenza vaccine - launching as Fluad Tetra - has received ...

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European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma

21 January 2020 - Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b. ...

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Shionogi receives European Union Marketing Authorisation for lusutrombopag for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures

22 February 2019 - The approval of lusutrombopag is based on two pivotal Phase 3 randomised clinical trials, L-PLUS1 and L-PLUS2. ...

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Market approval for drugs in the EU: time to change direction?

22 September 2017 - Since 1995, the EMA has been the EU authority responsible for assessing the efficacy, safety and ...

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European Commission approves expanded use of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism in children with end-stage renal disease on dialysis

31 August 2017 - Amgen today announced that the European Commission has granted marketing authorisation of a paediatric formulation (granules in ...

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European Commission grants AbbVie's Maviret (glecaprevir/pibrentasvir) marketing authorisation for the treatment of chronic hepatitis C in all major genotypes (GT1-6)

28 July 2017 - AbbVie's investigational, pan-genotypic HCV treatment is also under priority review by the U.S. FDA. ...

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AbbVie receives CHMP positive opinion for Humira (adalimumab) for the treatment of paediatric patients with chronic non-infectious anterior uveitis

21 July 2017 - The CHMP opinion is based on results from SYCAMORE, an investigator-initiated clinical trial. ...

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European Commission approves Brineura (cerliponase alfa), the first treatment for CLN2 disease, a form of Batten disease and ultra-rare brain disorder in children

1 June 2017 - Dosing includes all ages from birth for this fatal and rapid paediatric neurodegenerative condition Brineura is ...

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Alnylam receives European Medicines Agency PRIME designation for accelerated assessment of givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias

1 March 2017 - Alnylam Pharmaceuticals announced today that the EMA has granted access to its Priority Medicines (PRIME) scheme ...

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How big data can be used for the development and regulation of medicines

8 November 2016 - EMA workshop broadcast live on 14-15 November. ...

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EMA Management Board: highlights of October 2016 meeting

7 October 2016 - Board elects Grzegorz Cessak as vice-chair, adopts Agency’s mid-year report and signs off reflection paper on ...

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