Product: Drugs Recipient: Recipient Name Konrad Rejdak, M.D. Konrad Rejdak, MD, PhD Samodzielny Publiczny SzpitalKliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8,20-090 LublinPoland [email protected] Issuing Office: […]

Summary Company Announcement Date: November 06, 2025 FDA Publish Date: November 07, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-specification endotoxin results Company […]

On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM). […]

Docket Number: FDA-2017-D-0040 Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products This guidance is intended […]

Product: Drugs Recipient: Glowface United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November 3, […]

Product: Drugs Recipient: Derma Solution United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November […]

Product: Drugs Recipient: MJS Medicals South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November […]

Product: Drugs Recipient: Meamo South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November 3, […]

Product: Drugs Recipient: Glam Derma Netherlands Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November 3, […]