FDA letter monthly archive

FDA Letters Issued in September 2025

Name: FDA Letters Issued in September 2025
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in September 2025. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Sentynl Therapeutics, Inc. (Sep 30, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 30, 2025
US FDA• ZYCUBO
CRLComplete Response Letter
Complete Response Letter Biogen, Inc. (Sep 22, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 22, 2025
US FDA• SPINRAZA
CRLComplete Response Letter
Complete Response Letter Scholar Rock, Inc. (Sep 22, 2025)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 22, 2025
US FDA• BLA 761463

Complete Response Letter Sentynl Therapeutics, Inc. (Sep 30, 2025)

Complete Response Letter Biogen, Inc. (Sep 22, 2025)

Complete Response Letter Scholar Rock, Inc. (Sep 22, 2025)