US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

There are five novel agents with October 2021 goal dates on the FDA’s user fee calendar, but at least one – Omeros Corporation’s narsoplimab – already appears unlikely to see a decision, let alone an approval.

The FDA notified Omeros of “deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time,” the company announced...