The Food and Drug Administration has approved 21 new drugs so far in 2017, with several regulatory decisions set to be made this month, according to Zacks Investment Research.
Here are six companies awaiting regulatory decisions this month, as listed by Zacks.
- The biopharmaceutical company Alkermes seeks approval for a two-month dosing option of its schizophrenia drug Aristada. The company, which currently offers one-month and six-week dosing options, expects a decision June 5.
- Ligand Pharmaceuticals partnered with Melinta to develop Baxdela, a treatment for patients with acute bacterial skin and skin structure infections. The companies expect a response from the FDA June 19.
- Shire will learn if its new once-daily treatment for attention deficit hyperactivity disorder is approved on June 20.
- Neos Therapeutics expects to hear from the FDA June 19 regarding review of a different ADHD treatment.
- Portola Pharmaceuticals seeks approval for betrixaban, an anticoagulant used to treat acutely ill patients at risk of venous thromboembolism, a type of blood clot that forms in the vein. The drugmaker expects a decision June 24.
- Roche on June 26 will learn if the FDA approved a subcutaneous form of its best-selling cancer drug Rituxan.
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