Here are six companies awaiting regulatory decisions this month, as listed by Zacks.
1. Mylan will learn if its biosimilar version of Roche’s cancer drug Herceptin earns FDA approval this month.
2. Merck is seeking expanded approval for its drug Keytruda to treat a form of esophageal cancer. The drugmaker expects a response from the FDA Sept. 22.
3. Amgen and Allergan will learn if their biosimilar version of Roche’s cancer drug Avastin earns FDA approval Sept. 14.
4. Bristol-Myers Squibb expects to hear from the FDA regarding an expanded approval for its drug Opdivo Sept. 24. The drugmaker is seeking approval to use the drug as a follow up treatment for patients with hepatocellular carcinoma.
5. Johnson & Johnson seeks FDA approval for its rheumatoid arthritis drug Plivensia. The drugmaker expects a response Sept. 23.
6. Neos Therapeutics will learn if the FDA approves its attention deficit hyperactive disorder drug Sept. 15.
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