For Immediate Release: December 27, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, […]

Research Partnerships FDA is engaged with the following institutions to conduct research to help inform the public and the agency’s policies regarding compounded drugs: National Academies […]

Docket Number: FDA-2024-D-4490 Issued by: Guidance Issuing Office Oncology Center of Excellence The FDA is announcing the availability of a draft guidance for industry entitled “Combined […]

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 […]