Heron Therapeutics, Inc.

FDA approves Heron Therapeutics' VAN for ZYNRELEF, simplifying aseptic preparation and reducing withdrawal time to 20-45 seconds, expected to launch Q4 2024.

FDA decision deadlines include Vanda's tradipitant for gastroparesis (Sept 18), Zevra's arimoclomol for Niemann-Pick disease type C (Sept 21), Heron's extended-release needle for Zynrelef (Sept 23), Merck's Keytruda for pleural mesothelioma (Sept 25), and Bristol Myers Squibb's KarXT for schizophrenia (Sept 26). Sanofi and Regeneron await FDA verdict on Dupixent for COPD (Sept 27).