Pharma & Life Sciences

FDA Petition Attachment - Content Restricted

FDA received a petition (FDA-2026-P-3664) with restricted attachment content. The document appears to be a regulatory filing submitted to the agency. Specific substance and scope cannot be determined due to copyright restrictions on the attachment.

VYLOY Patent Extension Notice Comment

FDA is accepting public comments on a patent term extension notice for VYLOY (cisplatin), a chemotherapy drug. Comments are being submitted through Regulations.gov docket FDA-2025-E-0863. The notice relates to potential patent term extension eligibility under the Drug Price Competition and Patent Term Restoration Act.

ZIIHERA Patent Extension Comment Form

FDA has opened a public comment period on Regulations.gov for a patent extension related to ZIIHERA. The comment form is accessible for submission of feedback by interested parties including pharmaceutical companies, manufacturers, and individuals. The docket number is FDA-2025-E-0372-0005.

Background Material Supporting Proposed Regulatory Action

The FDA published background material supporting docket FDA-2026-P-3665. This document provides supplementary information related to a proposed regulatory action in the pharmaceutical or medical product space. The docket is open for public review and potential comment submission.

VYLOY Regulatory Review Period Patent Extension Comment Form

FDA opened a public comment period on the regulatory review period patent extension for VYLOY (vonoprazan), a potassium-competitive acid blocker approved for gastric acid-related conditions. Comments are being accepted through regulations.gov docket FDA-2025-E-0845. Stakeholders may submit comments on behalf of themselves, organizations, or anonymously.

VYLOY Patent Extension Application Comment Period

FDA opened a 60-day public comment period on a patent term extension application for VYLOY, a drug product. Commenters may submit feedback through regulations.gov regarding this application.

VYLOY Patent Extension Comment Period Notice

The FDA has opened a 60-day public comment period for a patent extension application related to the drug VYLOY (zolbetuximab). Pharmaceutical companies and other interested parties may submit comments on the patent term restoration matter. The comment period provides an opportunity for stakeholders to voice concerns or support regarding the extension.

Patent Extension Comment Period

FDA has opened a 60-day public comment period for a patent extension matter under docket FDA-2025-E-3074-0006. The agency is seeking stakeholder input on the EMRELIS patent extension proposal. Interested parties may submit comments through Regulations.gov.

ENFLONSIA Patent Extension Consultation

The FDA is seeking public comments on an ENFLONSIA patent extension application (Docket FDA-2025-E-3626-0006). Comments must be submitted by June 2, 2025 via Regulations.gov. This consultation follows standard FDA procedures for pharmaceutical patent-related matters.

INJECTAFER Regulatory Review Period for Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) for purposes of patent extension under 35 U.S.C. 156. The Agency published this notice as required by law following a patent extension application submitted to the USPTO. Any person with knowledge of incorrect dates may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.