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Biotech Stocks Facing FDA Decision In December

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With already 51 new molecular entities, or NMEs, getting greenlighted by the FDA so far this year, and still 1 more month to go, 2018 could be a banner year. This outpaces the 53 new drugs approved in 1996 - the highest ever.

A couple of firsts happened on the regulatory front in November.

On November 9, the FDA authorized the emergency use of DPP Ebola Antigen System, the first Ebola fingerstick test with portable reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated.

On November 20, the FDA approved Novimmune SA's Gamifant, the first treatment specifically for patients with primary hemophagocytic lymphohistiocytosis, a rare and life-threatening type of immune disease.

On a more official front in November, the U.S. regulatory agency announced that it is taking efforts to finding new ways to reduce the burden of chronic disease through improved nutrition, and also provide a way for animal drug developers to conduct certain types of research without the use of dogs.

Given the increasing number of cases of serious adverse events associated with the use of products containing Tianeptine, the FDA, on November 20, issued warning letters to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product. The products labeled as dietary supplements contain Tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in December 2018.

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