Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label

In a quiet week for approvals, the US Food and Drug Administration acted in two relatively underserved areas: the common condition bacterial vaginosis, where the FDA cleared Daré Biosciences’ Xaciato, and non-opioid post-operative pain management, where the indication for Heron Therapeutics, Inc.’s Zynrelef was expanded.

As the only new molecular entity and the only oncologic on the recent submissions list, Spectrum Pharmaceuticals Inc. and Hanmi Pharmaceutical Co., Ltd