On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across approved adult, solid […]
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
Submit Comments by 02/28/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
Docket Number: FDA-2024-D-5601 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
Docket Number: FDA-2024-D-5580 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]
Docket Number: FDA-2022-D-1562 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]
Glucagon-like peptide 1 (GLP-1) medications have become a powerful weight loss tool in a country where 40% of the population is obese. Patients taking these medications […]
TOPLINE: Coffee consumption is associated with the abundance of the gut bacterium Lawsonibacter asaccharolyticus, suggesting that specific foods can affect the intestinal microbiome. METHODOLOGY: The researchers […]
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