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EMA/FDA

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

The U.S. Food and Drug Administration today (October 5) approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to…

Update on EMA’s Brexit preparedness

The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, as announced at the beginning of August 2018. The temporary…

EMA panel backs two new HIV drugs

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck Sharp…

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…

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