The week of December 28, 2025, saw significant advancements in the healthcare sector, marked by key approvals and regulatory updates from the US Food and Drug Administration (FDA). Among the highlights, StimLabs received FDA 510(k) clearance for its innovative wound care product, Theracor. This marks a milestone as it becomes the first human umbilical cord-derived medical device available in a sheet format.
On December 30, the FDA approved Vanda Pharmaceuticals’ tradipitant, branded as Nereus, for the prevention of motion sickness-related vomiting. This decision is notable as it represents the first new pharmacologic treatment for motion sickness in over 40 years. The approval was based on data from two phase 3 clinical trials, Motion Syros and Motion Serifos, which demonstrated that tradipitant significantly reduced vomiting and severe nausea compared to placebo.
In a contrasting development, the FDA issued Complete Response Letters (CRLs) to Corcept Therapeutics and Outlook Therapeutics regarding their respective New Drug Applications. On December 31, Corcept received a CRL for relacorilant, a treatment for hypercortisolism. While the FDA recognized that the GRACE trial met its primary endpoint, it required additional evidence of effectiveness before considering the application favorably.
The same day, Outlook Therapeutics faced a CRL for its ONS-5010, intended for the treatment of wet age-related macular degeneration. The FDA’s decision followed two previous CRLs, indicating that the latest data provided did not sufficiently address concerns regarding the efficacy of the treatment.
In a more positive outcome, Axsome Therapeutics’ supplemental New Drug Application (sNDA) for AXS-05, aimed at treating agitation in Alzheimer’s disease, received acceptance and Priority Review from the FDA. This application is backed by extensive clinical data, including four randomized, double-blind, controlled phase 3 trials, along with a long-term safety trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026, for this potentially groundbreaking treatment.
These developments underscore the dynamic nature of the healthcare industry, where both innovations and regulatory hurdles shape the landscape for medical treatments. As healthcare professionals navigate this evolving environment, staying informed on these key updates is crucial for delivering optimal patient care.
