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EMA/FDA

ViiV Healthcare announces CHMP Positive Opinion for Dovato®

ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection -- Recommendation based on landmark GEMINI 1 & 2…

New long-lasting implant to treat opioid dependence

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant…

Letter to FDA regarding application for Descovy as PrEP

April 16, 2019 – Treatment Action Group (TAG) and PrEP4All sent a letter to Dr. Debra Birnkrant of the US Food and Drug Administration (FDA), outlining and expressing their serious…

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

The U.S. Food and Drug Administration today (April 8) approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in…

Gilead submits supplemental New Drug Application to FDA for once-daily Descovy® for PrEP

Gilead submits supplemental New Drug Application to U.S. Food and Drug Administration for once-daily Descovy® for HIV Pre-Exposure Prophylaxis - Filing supported by data demonstrating non-inferiority compared to Truvada® coupled…

Dynavax announces EMA accepts MAA for HEPLISAV-B® for prevention of hepatitis B in adults

BERKELEY, Calif., March 28, 2019 -- Dynavax Technologies Corporation (NASDAQ:DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, today announced that the European Medicines Agency (EMA) has accepted the…

EMA communication: Q&A: EU actions to prevent medicine shortages due to Brexit

EMA has published a questions-and-answers (Q&A) document for patients, healthcare professionals and the general public on the preparatory work that European Union authorities are doing to prevent medicine shortages due…

CytoDyn submits first part of biologics license application to FDA for leronlimab (PRO 140)

CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV -- FDA previously granted Rolling Review for…

EMA now operating from Amsterdam

As of today (March 11), EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its staff will gradually move…

Booklet on EMA pre-submission and assessment processes

The European Medicines Agency (EMA) has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to…