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EMA/FDA

ContraVir receives HBV IND approval for tenofovir exalidex (TXL™) in the US

EDISON, N.J., Sept. 11, 2017 -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and…

CytoDyn provides further update on PRO 140 pivotal combination therapy trial in patients with HIV

VANCOUVER, Washington, Sept. 06, 2017 -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the…

EMA: Reporting side effects of medicines

EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects The European Medicines Agency (EMA) has launched a survey to better…

VBI Vaccines to advance Phase 3 study for Sci-B-Vac

VBI Vaccines announces FDA acceptance of Investigational New Drug Application for Sci-B-Vac® Phase 3 clinical program -- Sci-B-Vac® is a third-generation hepatitis B vaccine, approved for use in Israel and…

Strengthening EU-US cooperation in medicine inspections

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European…

FDA: Revisions to the GENVOYA label approved

On August 15, 2017, the FDA approved revisions to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) package insert to include 144 week safety, efficacy and resistance data from Studies…

FDA panel supports licensing two-dose hepatitis B vaccine

Heplisav-B, Dynavax Technology's experimental hepatitis B vaccine, was recommended for licensing at a meeting of the US Food and Drug Administration's (FDA's) Vaccines and Related Biological Products Advisory Committee on…

First generic dolutegravir-based combination receives Tentative Approval from FDA

The Medicines Patent Pool welcomes first generic dolutegravir-combination to receive Tentative Approval from U.S. Food and Drug Administration Geneva, 08 August 2017 — The Medicines Patent Pool (MPP) welcomes its…

FDA grants priority review for investigational regimen for the treatment of HIV

Gilead announces U.S. FDA Priority Review Designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV -- Final FDA decision anticipated by February 12, 2018 FOSTER…

FDA approves expanded labeling for Epclusa to include use in patients co-infected with HIV

U.S. FDA approves expanded labeling for Epclusa® (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV – New data for first approved pan-genotypic once-daily single tablet…