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Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD worldpharmanews
March 27, 2019
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.
Boehringer Ingelheim files for regulatory approval of nintedanib pharmaceutical-technology
March 20, 2019
Boehringer Ingelheim has filed regulatory submissions with the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Adjusted fees for EMA applicants from April 1st europeanpharmaceuticalreview
March 07, 2019
The EMA has announced that fees for new drug applications will be different from the beginning of April 2019, taking into account the rate of inflation…
EMA’s CHMP meeting recommends eight medicines for approval pharmaceutical-technology
March 05, 2019
The European Medical Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight medicines for approval at its February meeting...
EMA follows FDA in putting Pfizer’s Xeljanz under the microscope for safety concerns fiercepharma
March 04, 2019
Xeljanz’s worrisome safety signal has been picked up across the pond. After the FDA issued an alert on the Pfizer blockbuster early this week, the European Medicines Agency said it's kicking off a review of its own.
EMA panel backs approval of AstraZeneca, Merck & Co.'s PARP inhibitor Lynparza in breast cancer firstwordpharma
March 04, 2019
AstraZeneca and partner Merck & Co. on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of the PARP inhibitor Lynparza (olaparib) as monotherapy for the treatment of HER2-nega
EMA Completed Pre-Approval Inspection of cGMP DS and DP Facilities for Trogarzo™ at WuXi Biologics en-cphi.cn
February 19, 2019
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery
Eisai seeks EMA approval for Fycompa to treat epilepsy in paediatrics pharmaceutical-technology
February 15, 2019
Eisai has submitted an application to the European Medicines Agency (EMA) seeking approval for the use of its Fycompa (perampanel) medicine to treat paediatric patients suffering with epilepsy....
EMA set for official move from London on 1 March pharmaphorum
January 25, 2019
The European Medicines Agency (EMA) has officially taken over its new building in Amsterdam in preparation of its move to the Dutch capital from London.
Ustekinumab could be approved to treat ulcerative colitis europeanpharmaceuticalreview
January 09, 2019
Ustekinumab has been submitted to be the first interleukin (IL)-12/23 inhibitor licensed for the treatment of ulcerative colitis…

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