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Biotech Stocks Facing FDA Decision In August


We are well into the second half of 2017. As yet another month comes to an end, let's take a look back at some of the FDA approval announcements that hit the headlines in July.

Endari, approved on July 7, 2017 for patients with sickle cell disease, marks the first approval for this rare blood disorder in nearly 20 years. Endari is manufactured by privately-held Emmaus Medical Inc.

Health care giant Johnson & Johnson subsidiary Janssen Biotech Inc.'s Tremfya was approved for the treatment of adult patients with moderate-to-severe plaque psoriasis on July 13, 2017. This drug becomes the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis.

On July 17, 2017, the FDA approved Puma Biotechnology Inc.'s (PBYI) Nerlynx, the first extended adjuvant therapy for early-stage, HER2-postive breast cancer.

Another new drug that was given thumbs up by the FDA is Gilead Sciences Inc.'s (GILD) Vosevi for hepatitis C, approved on July 18, 2017. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug Sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.

Aspect Imaging Ltd's Embrace Neonatal MRI System received FDA clearance on July 20, 2017, becoming the first neonatal magnetic resonance imaging device to get a regulatory green light.

Now, let's take a look at the biotech stocks awaiting word from the FDA in August.

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