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The HCPFive: Top News for Healthcare Providers from the Week of 12/28
Stay updated with the latest healthcare breakthroughs, including FDA approvals and CRLs, in this week’s essential news roundup.
Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.
Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) 510(k) clearance of StimLabs’ Theracor for wound care, the approval of tradipitant (Nereus) for motion sickness, Complete Response Letters (CRL) for Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration, and the acceptance and Priority Review of Axsome Therapeutics’ supplemental New Drug Application for AXS-05 for the treatment of agitation in Alzheimer’s disease.
With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of December 28, 2025—let’s jump in!
FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care
On December 29, 2025, the FDA granted 510(k) clearance to StimLabs’ Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation. The clearance builds upon the Agency’s prior authorization of Corplex P, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format.
FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion
On December 30, 2025, the FDA approved Vanda Pharmaceuticals’ tradipitant under the brand name Nereus for the prevention of vomiting induced through motion sickness. The decision marked the first new pharmacologic treatment in motion sickness in more than 4 decades and was based on data from a pair of phase 3 trials, Motion Syros and Motion Serifos, showing lower vomiting and severe nausea with tradipitant versus placebo.
FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism
On December 31, 2025, the FDA issued a CRL to Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism. While the Agency acknowledged the GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.
FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
On December 31, 2025, the FDA issued a CRL to Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration. The latest CRL adds to 2 previous CRLs in ONS-5010’s lengthy regulatory road, with the FDA determining that the additional mechanistic and natural history data provided in the newest resubmission failed to alter the previous review conclusion, which stated that confirmatory evidence of efficacy must be submitted to support the application. At the time of the CRL, the FDA had not yet indicated what type of confirmatory evidence would be acceptable.
FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation
On December 31, 2025, the FDA accepted and granted Priority Review to Axsome Therapeutics’ supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation in Alzheimer’s disease, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. The sNDA was supported by data from the comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including 4 randomized, double-blind, controlled phase 3 clinical trials and a long-term safety trial.
References
Hillenbrand A. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care. HCPLive. December 29, 2025. Accessed January 2, 2025. https://www.hcplive.com/view/fda-grants-510-k-clearance-first-umbilical-cord-derived-sheet-formulation-wound-care
Livingston R. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion. HCPLive. December 31, 2025. Accessed January 2, 2025. https://www.hcplive.com/view/fda-approves-tradipitant-nereus-for-the-prevention-of-vomiting-induced-by-motion
Livingston R. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism. HCPLive. December 31, 2025. Accessed January 2, 2025. https://www.hcplive.com/view/fda-issues-complete-response-letter-for-relacorilant-for-hypercortisolism
Livingston R. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD. HCPLive. December 31, 2025. Accessed January 2, 2025. https://www.hcplive.com/view/fda-issues-complete-response-letter-for-ons-5010-for-wet-amd
Livingston R. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation. HCPLive. December 31, 2025. Accessed January 2, 2025. https://www.hcplive.com/view/fda-accepts-grants-priority-review-to-axs-05-snda-for-alzheimer-s-disease-agitation
