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Biotech Stocks Facing FDA Decision In October 2020

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As another month comes to a close, we take a look back at some of the highlights of the regulatory front, before looking forward to what October brings.

New data from the 2020 National Youth Tobacco Survey (NYTS), released by the FDA in partnership with the Centers for Disease Control and Prevention, show that about 3.6 million U.S. youth currently use e-cigarettes compared to 5.4 million in 2019. This is indeed good news. However, a lot of work remains to be done and the FDA is doing all it can to curb youth use of e-cigarettes.

On September 9, the FDA issued warning letters to XL Vape LLC, Flavour Warehouse Ltd., and Pretty Women UK Ltd. which have been selling or distributing unauthorized electronic nicotine delivery systems (ENDS) products, to remove those products from the market.

Opioid overdose is another health crisis plaguing the country. According to a report by the New York Times, the year 2020 will witness the sharpest increase in annual overdose deaths since 2016. There were 70,980 overdose deaths in 2019, an increase of 4.6% over 2018, as per the CDC data.

On September 10, the FDA issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online.

As of this writing, the FDA has approved 40 novel drugs so far this year compared to just 27 during the same period (Jan-Sep) last year.

Now, let's take a look at the biotech stocks facing FDA decision in October.

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