Opportunity
Federal Register #FDA-2025-E-0501
FDA Regulatory Notice: Review Period for UNLOXCYT and Approval of MRESVIA
Buyer
Food and Drug Administration
Posted
April 16, 2026
Respond By
October 13, 2026
Identifier
FDA-2025-E-0501
This notice from the Food and Drug Administration (FDA), part of the Department of Health and Human Services, provides regulatory updates related to human biological products: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Checkpoint Therapeutics, Inc. (developer of UNLOXCYT) - Products/Services Mentioned: - UNLOXCYT (cosibelimab-ipdl): Human biological product for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation - Regulatory review period determined: 2,000 days (1,289 days testing, 711 days approval) - MRESVIA (Respiratory Syncytial Virus Vaccine): Approved as a material threat medical countermeasure - Unique/Notable Requirements: - This is a regulatory notice regarding the determination of the review period for patent extension purposes (not a procurement or contract opportunity) - Public comments or petitions are invited regarding the determination and due diligence of the applicant - Locations: - FDA offices in Rockville, MD - U.S. Patent and Trademark Office (USPTO) - No products or services are being procured or awarded; this is strictly a regulatory action related to patent extension and product approval.
Description
The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product UNLOXCYT, which is used to treat adults with metastatic or locally advanced cutaneous squamous cell carcinoma. This determination is published as required by law following an application to the U.S. Patent and Trademark Office for a patent extension. The regulatory review period includes a testing phase of 1,289 days and an approval phase of 711 days, totaling 2,000 days. Interested parties may submit comments or petitions regarding the dates or due diligence of the applicant by specified deadlines.