On this page Over-the-Counter Drug Research Evaluation of Sunscreen Active Ingredients DARS has conducted two randomized clinical trials which demonstrated systemic exposure of multiple commonly used […]

Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of […]

Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: […]

Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Oxycodone […]

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and […]

Docket Number: FDA-2025-D-0610 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

For Immediate Release: September 10, 2025 Despite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as […]

For Immediate Release: September 09, 2025 The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein […]

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder […]