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Three medicines step closer to EU approval pharmatimes
May 03, 2018
Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal ...
UK pharma calls for cooperation as EMA continues Brexit split pharmaphorum
April 23, 2018
Britain’s pharma trade body has issued a fresh Brexit warning, saying it would be disadvantageous to both the UK and the EU if drugs regulation diverges as a result of the political changes.
EMA to review Sanofi’s Dupixent drug for asthma pharmaceutical-technolog
April 09, 2018
The European Medicines Agency (EMA) has agreed to review an application submitted by Sanofi for the use of Dupixent (dupilumab) to treat inadequately controlled moderate-to-severe asthma.
EMA agrees to review Sanofi's filing for dual SGLT-1/2 inhibitor sotagliflozin in type 1 diabetes firstwordpharma
March 30, 2018
Sanofi announced Thursday that the European Medicines Agency (EMA) has accepted to review its marketing application for the experimental oral drug sotagliflozin
EMA to review Sanofi’s type I diabetes therapy pharmatimes
March 30, 2018
The European Medicines Agency has accepted for review Sanofi's experimental type I diabetes therapy sotagliflozi.
EMA recommends authorisation to Amglidia for neonatal diabetes europeanpharmaceuticalreview
February 27, 2018
Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children…
EMA discusses future Amsterdam premises europeanpharmaceuticalreview
February 08, 2018
The EMA Management Board have met in an extraordinary session to discuss EMA’s future premises in Amsterdam…
EMA committee recommends seven therapies from Roche, GSK, MSD and more pharmafile
January 30, 2018
The European Medicines Agency’s Committee for Medicinal Products for Human Use has voiced its recommendation of a raft of products in a number of therapeutic areas, including candidates from GlaxoSmithKline, Roche and MSD.
EMA accepts Marketing Authorization Application for romosozumab in the treatment of osteoporosis europeanpharmaceuticalreview
January 09, 2018
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture…
EMA accepts marketing authorization applications for Mylan and Biocon’s proposed biosimilars biospectrumasia
December 04, 2017
European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim

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