September 23, 2025
Share on PinterestThe FDA will advise physicians about the potential risks of Tylenol during pregnancy. Getty Images The Trump administration said the FDA will begin notifying […]
September 22, 2025
CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In […]
September 22, 2025
For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) […]
September 22, 2025
The Office of Biostatistics (OB) conducts independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process for publication. OB research spans such […]
September 22, 2025
Docket Number: FDA-2025-D-0918 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
September 20, 2025
Share on PinterestTwo new studies found that higher doses of semaglutide safely led to greater weight loss with minimal side effects. Olena Malik/Getty Images Researchers say […]
September 19, 2025
Share on PinterestExperts say everyone who is eligible should get vaccinated against influenza this fall. Getty Images/Maskot Health officials anticipate this winter’s flu season to be […]
September 19, 2025
For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth […]
September 19, 2025
FDA researchers are investigating the utility of pharmacodynamic, or PD, biomarkers to demonstrate biosimilarity. This research can potentially help developers demonstrate that their proposed product is […]
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