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EMA/FDA

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…

FDA requests comment on international classification of marijuana, to be reviewed by WHO

Forbes: Feds want input on marijuana reclassification “…he United Nations World Health Organization is set to launch a review of the current international classification of marijuana, THC, cannabidiol, and other…

Cocrystal Pharma to study CC-31244 for the treatment of hepatitis C

Cocrystal Pharma receives FDA clearance to initiate Phase 2a clinical study evaluating CC-31244 for the treatment of hepatitis C virus – Company on track to commence patient enrollment and dosing…

ViiV Healthcare gains CHMP Positive Opinion for Juluca in Europe

London, 23 March 2018 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee…

Eiger BioPharmaceuticals announces positive guidance following FDA meeting on hepatitis delta virus registration program

Phase 3 D-LIVR trial planned to initiate in second half 2018 PALO ALTO, Calif., March 21, 2018 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted…