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EMA/FDA

EMA’s Business Continuity Plan for Brexit published

Plan aims to ensure continuity of Agency’s operations The European Medicines Agency (EMA) has published today its Brexit Preparedness Business Continuity Plan. The plan aims to safeguard continuity of EMA’s…

Better labelling of excipients for safe use of medicines

Updated annex to excipient guidelines has new safety advice for 15 excipients The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients…

EMA publishes comments on Member States’ hosting bids

Accessibility for delegates and experts and staff retention are key to ensure Agency’s ability to function The European Medicines Agency (EMA) is today publishing the information it submitted to the…

FDA approves changes to the labels of DESCOVY and NORVIR Oral Solution

FDA recently approved changes to the labels of DESCOVY and NORVIR (ritonavir) Oral Solution. The approved changes are detailed here (for DESCOVY) and here (for NORVIR Oral Solution).

FDA approves changes to the Epivir label

FDA recently approved changes to the EPIVIR (lamivudine) package insert. The approved changes are detailed here.

European Commission approves Symtuza® for the treatment of HIV-1 in adults and adolescents in Europe

Symtuza® is the only darunavir-based single-tablet regimen (STR) approved for the treatment of HIV-1 in the European Union BEERSE, Belgium, September 26, 2017--Janssen-Cilag International NV (Janssen) today announced that the…

Janssen submits new drug application to FDA for the first darunavir-based single tablet regimen for the treatment of HIV-1

Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir…

Update on EMA relocation preparedness

Staff survey indicates that the future of public health in Europe is at stake To complement the European Commission’s assessment of all bids for the relocation of the Agency submitted…

Highlights from the CHMP September meeting

At its September meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval a generic version of ritonavir – Ritonavir Mylan (ritonavir) for the…

FDA grants orphan drug designation to Lambda for HDV

FDA granted orphan drug designation to Eiger BioPharmaceuticals for its pegylated interferon lambda 1a, known as Lambda, to treat chronic hepatitis delta virus infection, according to a press release. Lambda,…