Biotech Stocks Facing FDA Decision In June

(RTTNews) - The month of May saw the FDA greenlight 5 new drugs, including 1 new molecular entity, and surprisingly turn down 1 drug candidate, whose approval was considered a no-brainer by some experts.

The new molecular entity to get the FDA's blessing is Roche's Tecentriq, a PD-L1 inhibitor, to treat the most common type of bladder cancer, called urothelial carcinoma. Tecentriq was approved on May 18, 2016, four months ahead of the decision date.

The FDA decision that came as a shocker was that on AstraZeneca's hyperkalemia drug ZS-9. The company was handed down a Complete Response Letter for ZS-9 on May 27, 2016, referring to observations arising from a pre-approval manufacturing inspection. However, no new clinical data was sought by the regulatory agency.

With June just around the corner, it's time to take a look at the upcoming FDA decisions of the month.