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EMA/FDA

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…

FDA: Intelence indication expanded to include younger HIV patients

The Food and Drug Administration (FDA) has approved updated labeling for Intelence (etravirine; Janssen) to include treatment-experienced pediatric patients 2 to <6 years of age weighing ≥10kg for the treatment…

EMA: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines The European Union (EU) and Japan have agreed to broaden the range…

FDA approves SYMTUZA

Janssen announces U.S. FDA approval of SYMTUZA (D/C/F/TAF), the first and only complete darunavir-based single-tablet regimen for the treatment of HIV-1 infection Read the press release here.