As we approach August, it is time for our regular review of the critical FDA decisions on the horizon.
Thus far this year, the FDA has approved 22 novel drugs, a slight reduction compared to the 29 approvals achieved during the same period last year. ("Novel" drugs are new medications that have never before been approved or marketed in the U.S.; Source: FDA).
Additionally, August is recognized as Spinal Muscular Atrophy (SMA) Awareness Month. SMA is a rare genetic neurodegenerative disorder characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk, and progressive muscle weakness.
SMA is typically fatal and commonly diagnosed in young children, and while there is no complete cure, approved therapies can manage the symptoms of this neuromuscular disease. Notable treatments include Biogen's Spinraza, Novartis' Zolgensma, and Roche's Evrysdi.
Now, let us examine the biotech stocks that are facing FDA decisions this August.
