Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States WARNING LETTER 694688 December […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Curtis Miller Prime Vitality, Inc. dba Prime Peptides 735 State St., Ste 422Santa Barbara, CA 93101United States […]

Summary CDER researchers are developing an approach that enables sharing and analyzing large volumes of cardiac electrophysiology in vitro data and streamlines the analysis and interpretation […]

Español 药物安全通讯 Drug Safety Podcast 12-16-2024 UpdateFDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with […]

Historically, for topical drug products applied to the skin, bioequivalence (BE) has often been established based on comparative clinical endpoint BE studies. However, such studies are […]

For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen […]

On December 13, 2024, the Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic […]

For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, […]

Summary Company Announcement Date: December 12, 2024 FDA Publish Date: December 13, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]