Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER December 12, 2025 RE: 719339 Musclepower Enterprise Ltd. dba MONSTER KING […]

Delivery Method: Via Email Reference #: 320-26-25 Product: Drugs Recipient: Recipient Name Mr. Ross Sklar Recipient Title Chief Executive Officer Sklar Personal Care Inc. 3137 East […]

The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart […]

On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults […]

Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance recommends approaches that sponsors […]

Docket Number: FDA-2020-D-2099 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidance provides recommendations for sponsors and sponsor-investigators to comply with the […]

Docket Number: FDA-2021-D-0368 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]