FDA Accepts Bristol Myers’ Application for Injectable Opdivo (NYSE:BMY)

The FDA accepted Bristol-Myers (NYSE: BMY) biologics license application for a subcutaneous formulation of its oncology drug Opdivo, also known as nivolumab, with a target action date of February 28.

The subcutaneous version is formulated with Halozyme (NASDAQ:HALO) owner recombinant human hyaluronidase. Opdivo is currently administered by IV.

The IV formulation of Opdivo is approved in more than 65 countries to treat a wide variety of cancers, including non-small cell lung cancer, kidney cancer, colorectal cancer and melanoma.