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EMA/FDA

FDA says Prezcobix should not be given to pregnant women

Darunavir/cobicistat — marketed as Prezcobix (Janssen) in the United States — should not be given to pregnant women with HIV because of substantially lower exposures of the two medications during…

Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 14 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted…

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top agency priority The U.S. Food and Drug Administration today (May 16) approved Lucemyra…

Juluca receives EU marketing authorisation

-- ViiV Healthcare's press release: ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV -- Janssen's press release: Janssen…

New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

While EMA review is ongoing, dolutegravir should not be used in women seeking to become pregnant The European Medicines Agency (EMA) is evaluating preliminary results from a study which found…

FDA approves expanded indication for Truvada®

U.S. Food and Drug Administration approves expanded indication for Truvada® (emtricitabine and tenofovir disoproxil fumarate) for reducing the risk of acquiring HIV-1 in adolescents First agent indicated for uninfected adolescents…

FDA releases Theratechnologies from post-approval commitments related to EGRIFTA®

MONTREAL, May 01, 2018 -- Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced that the Food and Drug Administration (FDA) has released Theratechnologies from post-approval commitments related to the approval of EGRIFTA®.…

European CHMP adopts positive opinion for Gilead’s Biktarvy®

In clinical trials, Biktarvy demonstrated high efficacy and zero resistance through 48 weeks FOSTER CITY, Calif., Apr. 27, 2018 -- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for…

Theratechnologies to seek regulatory approval of Trogarzo™ in Europe

Theratechnologies to seek regulatory approval of Trogarzo™ (ibalizumab) in Europe based on efficacy and safety data used for FDA approval MONTREAL, April 24, 2018 -- Theratechnologies Inc. (Theratechnologies) today announced…

EMA: Increasing oversight of API manufacturing through international collaboration

Report on the International API inspection programme published The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active…

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