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Are You Aware of the FDA's Plans for 2018?

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Hemostemix Announces US FDA Clinical Trial Approval

Hemostemix (TSXV:HEM), a clinical-stage, autologous cell-therapy company, is pleased to announce that the United States Food and Drug Administration has raised no objections to the Company’s Investigational New Drug application.  This allows the Company to expand its Phase II clinical trial for critical limb ischemia to enroll patients at clinical sites

Sientra Receives FDA Approval of PMA Supplement

Sientra (NASDAQ:SIEN) a medical aesthetics company, today announced U.S. Food and Drug Administration (FDA) approval of the Company’s PMA supplement allowing commercialization of its OPUS-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility.
As quoted in the press release:

Jeffrey M. Nugent, Chairman and Chief

Teligent Announces FDA Approval of Clobetasol Propionate Cream USP, 0.05%

Teligent (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Clobetasol Propionate Cream USP, 0.05%.  This is Teligent’s fourth approval for 2018, and its twenty-third approval from its

Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita

Ultragenyx Pharmaceutical (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, Kyowa Hakko Kirin Co. Ltd (Kyowa Hakko Kirin), and Kyowa Kirin International PLC (Kyowa Kirin International) today announced that the U.S. Food and Drug Administration (FDA) has approved Crysvita® (burosumab-twza) for the

Biomerica Announces Third Quarter Financial Results

Biomerica (Nasdaq:BMRA) today reported net sales of $4,433,785 for the nine months ending February 28, 2018, compared to $4,342,247 for the period ended February 28, 2017. Sales for the three months ending February 28, 2018 were $1,375,666 compared to $1,499,930 for the period ended February 28, 2017.

As quoted in the

Shire: FDA APPROVES VONVENDI

Shire (LSE: SHP, NASDAQ: SHPG), the global  biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease

Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM

Innovation Pharmaceuticals (OTCQB:IPIX) a clinical stage biopharmaceutical company, is pleased to report additional information from the Company’s successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving

2018 Genetics Market Report


Find out what to watch for in the world of genetics investing.


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