A year after its testosterone replacement therapy was spurned at the FDA, Antares Pharma has snatched an OK from an agency that has made its dislike for such treatments well known.

August was a pretty steady month for biotechs. In terms of new molecular entity or NME approvals, the month was productive, with the FDA giving the go-ahead for seven of these products containing active moieties that haven't been previously approved by the agency.

Several drug approvals came through this month and the second-quarter reporting season panned out to be a better one for biotechs, with large-caps reporting both earnings and revenue beats.

Now, here are the PDUFA catalysts that could trigger moves in the biotech space in September.