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EMA/FDA

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

May 23, 2019: Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause…

Research, regulatory and access considerations regarding pretomanid

TB CAB releases document outlining key considerations regarding pretomanid in anticipation of FDA public advisory committee meeting on the TB Alliance's new drug application for pretomanid. In March 2019, the…

Celgene announces POMALYST® granted Breakthrough Therapy designation from FDA for HIV-positive and negative Kaposi sarcoma

Celgene plans to submit sNDA by end of 2019 Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa SUMMIT, N.J., May 13, 2019 -- Celgene…

EMA: Working together for safe medicines in the EU

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective. As of today, EMA will start sharing a series of…

Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the…

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

The U.S. Food and Drug Administration today (April 30) approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to…

ViiV Healthcare submits NDA to FDA for the first long-acting, injectable treatment regimen for HIV

ViiV Healthcare submits New Drug Application (NDA) to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV -- If approved, cabotegravir and…

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…

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