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EMA/FDA

FDA approves changes to the Prezcobix label

On 16 June 2017 FDA approved changes to the Prezcobix (darunavir and cobicistat) tablet label. The changes are summarized here.

FDA approves changes to the Kaletra label

On 16 June 2017 FDA approved changes to the Kaletra (lopinavir/ritonavir) tablet and oral solution labels. The changes are summarized here.

VBI Vaccines reports results from discussion with FDA for hepatitis B vaccine

VBI Vaccines reports positive outcome from Phase III pre-IND discussions with the FDA for hepatitis B vaccine, Sci-B-Vac™ CAMBRIDGE, MASSACHUSETTS, June 19, 2017 - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI"), a…

Gilead submits new HIV drug application to FDA

Gilead submits New Drug Application to U.S. Food and Drug Administration for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for HIV treatment Investigational single tablet regimen may have potential…

Regulators in EU, Japan and US take steps to facilitate development of new antibiotics

EMA, PMDA and FDA align data requirements and agree on areas of convergence The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States'…

FDA approves generic Truvada; Gilead insists a generic version ‘will not be immediately available’

In a move that has taken HIV advocates by surprise and stewed considerable confusion, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster…

FDA approves first generic version of Truvada for treatment, prevention of HIV

The FDA approved the first generic version of Truvada for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in adults and children weighing at least 17 kg,…

America pulls opiod from market for first time amid crisis echoing HIV and crack epidemics

The epidemic is impacting people all across the country, and in significant numbers The US Food and Drug Administration is making an unprecedented move, and has ordered a drug manufacturer…

FDA approves new Norvir oral powder formulation

On June 7, 2017, the Food and Drug Administration approved a new Norvir (ritonavir) oral powder formulation, 100 mg packet. This approval provides for the use of Norvir (ritonavir) oral…

ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines

EU and US submissions for single tablet combining dolutegravir and rilpivirine Priority review voucher submitted in US with anticipated target action date of 6 months London, UK 01 June 2017…