December 15, 2025
On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults […]
December 15, 2025
Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance recommends approaches that sponsors […]
December 15, 2025
Docket Number: FDA-2020-D-2099 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The guidance provides recommendations for sponsors and sponsor-investigators to comply with the […]
December 15, 2025
Docket Number: FDA-2021-D-0368 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research […]
December 15, 2025
Share on PinterestCannabis derivatives may lead to new treatments for ovarian cancer. Image Credit: Bloomberg Creative Photos/Getty Images Early lab research shows that two cannabis compounds, […]
December 15, 2025
Share on PinterestMany popular holiday beverages are high in sugar and may damage bone health. Image Credit: Tamara Evsiukova/Stocksy Many popular holiday drinks, such as hot […]
December 13, 2025
Share on PinterestA new study found that a “beer belly” may be linked to harmful changes in the heart structure, especially in men. Image Credit: master1305/Getty […]
December 12, 2025
Criteria to Participate in the Emerging Technology Program To qualify for participation in the Emerging Technology Program, technologies need to: Have the potential to improve product […]
December 12, 2025
Benefits to participating in the Emerging Technology Program. Participants in the program can expect: Pre-submission face-to-face interactions with ETT members and review staff to answer technical […]
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