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Biotech Stocks Facing FDA Decision In September 2019

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The month of August saw some important decisions and a couple of firsts happening on the regulatory front.

In order to promote greater public understanding of the full scope of serious negative health consequences of cigarette smoking, the FDA on August 15, 2019, proposed new required health warnings with color images for cigarette packages and advertisements. The proposed rule is open for public comments for 60 days through October 15, 2019.

Turalio, the first therapy for symptomatic tenosynovial giant cell tumor, a rare joint tumor, received FDA approval on August 2, 2019. Developed by Daiichi Sankyo, the drug sports a boxed warning about the risk of serious and potentially fatal liver injury.

The first of its kind device to treat pediatric patients with progressive idiopathic scoliosis, the most common type of spinal deformity, also received the regulatory nod this month. The device, called The Tether - Vertebral Body Tethering System, is developed by Zimmer Biomet Spine.

As of this writing, 25 novel drugs have been approved year-to-date compared to 35 during the same period last year. It should be noted that 59 novel drugs were approved in full-year 2018, an all-time high for new drug approvals.

Now, let's take a look at the companies that await a ruling from the FDA in September 2019.

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