Biotech Stocks Facing FDA Decision In September

(RTTNews) - August proved to be a very busy month on the regulatory front, in terms of Novel Drug approvals, the ongoing efforts to restrict opioid abuse, and new efforts to encourage further advances in the rapidly evolving field of gene therapy.

Eight Novel Drugs were greenlighted by the FDA in August, the highest for a month so far this year. The month also witnessed a number of firsts in terms of approval.

On August 10, the FDA approved Onpattro, a first-of-its kind targeted RNA-based therapy for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.

The first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions secured FDA approval on August 16.

On August 22, the first drug, Oxervate for the treatment of neurotrophic keratitis, a rare eye disease, was given regulatory nod in the U.S.

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