The US Food and Drug Administration (FDA) has made significant strides in healthcare with recent approvals and clearances for various treatments. On December 29, 2025, the FDA granted 510(k) clearance to StimLabs for its product Theracor, a groundbreaking human umbilical cord-derived medical device designed for wound care. This approval follows the earlier authorization of the Corplex P, the first such device cleared by the FDA for wound management in a particulate format.
In a notable development on December 30, 2025, the FDA approved Vanda Pharmaceuticals’ tradipitant, marketed as Nereus, for the prevention of vomiting associated with motion sickness. This marks the first new pharmacological treatment for motion sickness in over four decades. The decision was based on results from two phase 3 trials, Motion Syros and Motion Serifos, which demonstrated significant reductions in vomiting and severe nausea compared to a placebo.
On December 31, 2025, the FDA issued Complete Response Letters (CRLs) to Corcept Therapeutics regarding its New Drug Application for relacorilant, aimed at treating hypercortisolism. Although the FDA acknowledged that the GRACE trial met its primary endpoint and data from the GRADIENT trial provided confirmatory evidence, additional evidence of effectiveness is required to support the approval.
Additionally, the FDA issued a CRL to Outlook Therapeutics for its ONS-5010 treatment for wet age-related macular degeneration. This latest CRL adds to two previous ones in the product’s regulatory journey, as the FDA concluded that the recent data submitted did not change its earlier stance, emphasizing the need for confirmatory evidence of efficacy.
Moreover, the FDA accepted and granted Priority Review to Axsome Therapeutics for its supplemental New Drug Application for AXS-05, intended for treating agitation in Alzheimer’s disease. This application, which will be reviewed by April 30, 2026, is backed by comprehensive data from a robust clinical development program, including four randomized, double-blind, controlled phase 3 trials and a long-term safety study.
These developments underscore the FDA’s ongoing commitment to advancing healthcare innovations and ensuring the safe and effective delivery of new treatments to patients. As healthcare providers navigate these changes, staying informed about regulatory updates and new therapies is crucial for improving patient care.