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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.
Feb 12, 2019
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.
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.
Jan 27, 2019
On September 8, 2018, Amarex’s President & CEO, Dr. Kazem Kazempour, keynoted at the Trans 2018 digital health conference in Taipei, Taiwan.
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.
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.
Aug 30, 2018
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.
Aug 19, 2018
Amarex Taiwan announces today that an oncology IND application has received a safe to proceed notification from the US FDA.