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EMA/FDA

EMA: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108 The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAPs) for which, based on current…

ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV

London, UK 14 September 2018 – ViiV Healthcare today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG)…

FDA approves Merck’s DELSTRIGO and PIFELTRO for the treatment of HIV

FDA approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a once-daily fixed-dose combination tablet as a complete regimen and PIFELTRO™ (doravirine), an NNRTI, both for the treatment of…

EMA: Towards improving the availability of medicines in the EU

EU-wide task force publishes work programme 2019/20 and prepares multi-stakeholder workshop The task force set up by European Union (EU) regulators to better address potential problems with medicines’ supply and…

Theratechnologies files marketing authorization application for Trogarzo™ in Europe

MONTREAL, Aug. 28, 2018 -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that the application for marketing authorization of Trogarzo™ (ibalizumab) was filed with the European Medicines Agency…

EMA updates on Viekirax and Victrelis

Viekirax (ombitasvir/paritaprevir/ritonavir) - change to existing contraindication Contraindicated in patients with moderate hepatic impairment Read more here.   ******************* Victrelis (boceprevir) - withdrawal of marketing authorization The marketing authorisation for…

EMA: working for every patient in Europe

A short video to explain who EMA is and what it does The European Medicines Agency (EMA) ensures that medicines available in the European Economic Area (EEA) are safe, effective…

FDA updates hepatitis C drug labeling to include new clinical data

The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies, according to a press…

Theratechnologies press releases: Trogarzo

European Medicines Agency confirms accelerated assessment procedure for Trogarzo™ The Committee for Medicinal Products for Human Use of the European Medicines Agency will review the application for marketing authorization of…

Brexit preparedness: EMA to further temporarily scale back and suspend activities

Next phase of business continuity plan aimed at securing essential public and animal health activities The European Medicines Agency (EMA) will launch the next phase of its business continuity plan…