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FDA letter monthly archive

FDA Letters Issued in July 2025

Browse FDA approval and complete response letters issued in July 2025. Each result links to a structured letter page with source PDF access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter

Complete Response Letter BLA 761303 (Jul 30, 2025)

This FDA communication outlines specific requirements for the resubmission of Biologics License Application (BLA) 761303, focusing on updated prescribing information, safety data, and general submission procedures. It emphasizes adherence to labeling regulations and guidance, and mandates the provision of comprehensive safety information from clinical trials and worldwide experience.

IssuedJul 30, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 761385 (Jul 30, 2025)

This FDA letter outlines deficiencies and requirements for Biologics License Application (BLA) 761385 for the drug TVB-009. It details specific instructions for updating labeling (content, carton, and container), resubmitting the proprietary name, and providing a comprehensive safety update. The letter also acknowledges the proposed Risk Evaluation and Mitigation Strategy (REMS) and sets a one-year deadline for resubmission or other actions.

IssuedJul 30, 2025
US FDA• TVB-009
CRLComplete Response Letter

Complete Response Letter NDA 505b1 218923 (Jul 30, 2025)

This FDA letter addresses deficiencies in NDA 218923, reserving comment on proposed labeling and proprietary name until the application is otherwise adequate. It mandates a comprehensive safety update, including detailed data presentation, and outlines specific requirements for resubmission within one year, emphasizing that a partial response will not be processed.

IssuedJul 30, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter NDA 505b1 205508 (Jul 28, 2025)

This document is a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) to an applicant for New Drug Application (NDA) 205508. The FDA has determined that the application cannot be approved in its present form due to several deficiencies related to facility inspections, manufacturing process controls (CMC data), and bioequivalence/bioavailability data reliability. The letter outlines specific reasons for non-approval and provides recommendations for addressing these issues, including requirements for resubmission and potential re-inspection of facilities.

IssuedJul 28, 2025
US FDA• Unknown
CRLComplete Response Letter

Complete Response Letter BLA 125827 (Jul 21, 2025)

The U.S. Food & Drug Administration (FDA) issued a Complete Response Letter for Replimune, Inc.'s Biologics License Application (BLA) for vusolimogene oderparepvec. Final approval cannot be granted due to significant clinical deficiencies in the RPL-001-16 and RP1-104 trials, which failed to provide substantial evidence of effectiveness or adequately isolate the drug's contribution, and unaddressed Chemistry, Manufacturing, and Controls (CMC) issues.

IssuedJul 21, 2025
US FDA• vusolimogene oderparepvec
CRLComplete Response Letter

Complete Response Letter BLA 125842 (Jul 9, 2025)

The FDA issued a Complete Response Letter for Capricor, Inc.'s Biologics License Application (BLA) for deramiocel, indicating that the application cannot be approved in its current form due to significant deficiencies in clinical data and lack of substantial evidence of effectiveness.

IssuedJul 9, 2025
US FDA• deramiocel
CRLComplete Response Letter

Complete Response Letter BLA 125845 (Jul 7, 2025)

The U.S. Food & Drug Administration (FDA) issued a Complete Response Letter to Ultragenyx Pharmaceutical Inc. for their Biologics License Application (BLA) for rebisufligene etisparvovec. The FDA concluded that final approval cannot be granted due to deficiencies primarily related to Chemistry, Manufacturing, and Controls (CMC) and outstanding clinical data requirements.

IssuedJul 7, 2025
US FDA• rebisufligene etisparvovec