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EMA/FDA

Theratechnologies announces FDA decision to extend the ibalizumab review period

Theratechnologies Inc. announced that it was notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration will extend its review of the Biologics License Application for…

FDA approves hepatitis C drugs label updates

FDA recently approved changes to the labels of: Sovaldi (sofosbuvir), Harvoni (ledipasvir and sofosbuvir), Epclusa (sofosbuvir and velpatasvir) and Vosevi (sofosbuvir, velpatasvir, and voxilaprevir). The approved changes are detailed here.…

Dynavax announces FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults

First and only two-dose vaccine in United States for prevention of hepatitis B in adults First new hepatitis B vaccine in United States in more than 25 years BERKELEY, CA…

Highlights from the CHMP November meeting

At its November meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval two generic versions of darunavir – Darunavir Krka and Darunavir Krka d.d.…

FDA guidance for industry on DAA development for hepatitis C

FDA published a final guidance on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. The guidance can be found at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm225333.pdf This guidance assists sponsors in the…

EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and antimicrobial consumption

ECDC, EFSA & EMA recommend set of indicators to measure progress in EU Member States A set of indicators will assist European Union (EU) Member States to assess their progress…

EMA: Unparalleled access to clinical data – one year on

Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback One year ago today (October 20), the European Medicines Agency (EMA) became the first regulatory authority to give…

FDA approves changes to the Reyataz label

FDA recently approved changes to the REYATAZ (atazanavir) package insert. The approved changes are detailed here.

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…

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