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: 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: 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: 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: COSMO KOREA South Korea Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER November […]

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, […]