July 2, 2025
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 drug, […]
July 2, 2025
Submit Comments by 09/01/2025 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 […]
July 2, 2025
Docket Number: FDA-2022-D-2301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
July 2, 2025
FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, […]
July 2, 2025
TOPLINE: Among Medicare beneficiaries with HIV, the proportion receiving at least one nonrecommended antiviral prescription decreased substantially from 5.1% in 2013 to 0.1% in 2021. METHODOLOGY: […]
July 2, 2025
TOPLINE: In a large cohort, long-acting lipoglycopeptides (laLGPs) demonstrated comparable effectiveness to standard-of-care antibiotics for step-down treatment of serious Gram-positive bacterial infections in both individuals who […]
July 2, 2025
TOPLINE: Kids and teens sleeping longer, even as little as an hour more, during the first week after a concussion were more likely to have worse […]
July 2, 2025
(Reuters) -Organon said on Wednesday it will the stop development of an experimental treatment it acquired through its purchase of Forendo Pharma, after the drug failed […]
July 2, 2025
TOPLINE: In paediatric-onset Crohn’s disease (CD), the colonic location of the disease was associated with higher risks for perianal disease and extraintestinal manifestations (EIMs), whereas the […]
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