The holiday season is upon us, and there is just a month left for the New Year. With a fairly good number of New Drug Applications awaiting decision in December, it is going to be a busy month for the FDA.
So far this year, 40 novel drugs have been approved, and that is only 6 short of beating the record of 2015, which marked a 19-year high in terms of novel drug approvals in the United States. In 2015, 45 novel drugs were approved. Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.
Before we take a look at the stocks awaiting FDA decision in December, here's a bit of what happened this month. November saw many firsts in terms of FDA approval.
Roche's Zelboraf, which received thumbs up from the FDA on November 6th, is the first drug to be approved for Erdheim-Chester Disease, a rare cancer of the blood. Innovative Health Solutions' NSS-2 Bridge, which received FDA clearance on November 15th, is the first device for use in helping to reduce the symptoms of opioid withdrawal.
On November 17th, the first telehealth option to program cochlear implants remotely received the FDA blessing. ViiV Healthcare's Juluca, which was approved on November 21st, is the first two-drug regimen for certain patients with HIV. The standard HIV regimens include three or more drugs.
RxSight IOL, approved on November 22nd, is the first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients.
Now, here's the list of biotech stocks that await a ruling from the FDA in December.
by RTTNews Staff Writer
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