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 […]

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-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 […]

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-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 […]

[12-26-2024] The Food and Drug Administration is advising consumers not to purchase or use Lucky Guy Platinum 18000, a product promoted and sold for sexual enhancement […]

[12-26-2024] The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Gummy, a product promoted and sold for sexual enhancement on […]

It is estimated that over 6.1 million people aged 12 or older have an opioid use disorder (OUD). Medications for opioid use disorder (MOUD) are an […]