Media / News Releases

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Mar 05, 2019

2018 Report: A Year of Successful US FDA Submissions

Amarex’s Regulatory Affairs Department is pleased to announce a record year for new regulatory submissions to the US FDA. 

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Feb 12, 2019

Featured White Paper: Understanding Adaptive Designs for Clinical TrialsAmarex-sponsored Team Awarded Gold Medal at the 2018 iGEM Competition

Amarex is pleased to announce that its sponsored team, NTHU_Formosa, was awarded a gold medal at the 2018 International Genetically Engineered Machine Competition (iGEM), held at the Massachusetts Institute of Technology (MIT) in Boston, MA. 

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Feb 06, 2019

Promoting Software as Medical Device (SaMD): Amarex Speaks Up

Global Biotechnology Monthly recently interviewed Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, about the US FDA’s continued support for the development and marketing of digital health application products.

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Jan 27, 2019

Watch Dr. Kazempour's Keynote Presentation and Press Room Interview at the Trans 2018 Digital Health Conference

On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan.

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Dec 30, 2018

Amarex Celebrates 20 Years of Clinical Product Development and Approvals

On December 30, 2018, Amarex celebrated its twentieth anniversary, commemorating two decades of clinical product development and approvals for our clients.

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Sep 23, 2018

Product Development Strategy: Let Amarex Negotiate Your FDA Approval

Amarex recently submitted an initial Pediatric Study Plan (iPSP) waiver request to the US FDA for a client’s product that is fast approaching the submission of an NDA. Amarex’s request for waiver was approved by the US FDA.

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Aug 30, 2018

US FDA Approves Diacomit for the Treatment of Seizures in Patients with Dravet Syndrome Taking Clobazam

Amarex Taiwan, LLC announces today that, on August 20, 2018, the US FDA approved Diacomit for the treatment of seizures in patients with Dravet Syndrome 2 years of age and older taking clobazam.

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Aug 19, 2018

IND for the First siRNA Oncology Drug, STP705, Filed and Deemed Safe to Proceed to Clinic by the US FDA

Amarex Taiwan announces today that an oncology IND application has received a safe to proceed notification from the US FDA.