March 6, 2024
The US Food and Drug Administration (FDA) has approved the first biosimilar to denosumab, denosumab-bddz (Wyost/Jubbonti). The biosimilar was also granted interchangeability status, which allows pharmacists […]
March 6, 2024
Overview of FDALabel DatabaseFDALabel Database AccessPotential UsersWhat is Included in Drug Labeling?Database FeaturesLive Queries Updates and StatisticsUser GuidesAdditional InformationOther ResourcesReferencesContact InformationDisclaimer FDALabel Version 2.8.2 Provide feedback or request […]
March 6, 2024
To promote transparency and communication, FDA is sharing a list of disease areas where a letter of intent (LOI) has been submitted and ongoing plans exist […]
March 6, 2024
Hypoparathyroidism EL-PFDD MeetingHost: HypoPARAthyroidism Association Report pending March 5, 2024 Dry Age-Related Macular Degeneration (Dry AMD) EL-PFDD MeetingHost: Foundation Fighting Blindness Report pending March 1, 2024 […]
March 6, 2024
Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy The Food and Drug Administration (FDA or Agency) […]
March 6, 2024
The FDA Compounding Quality Center of Excellence conducts the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between […]
March 6, 2024
TOPLINE: Habitual short sleep duration was associated with an increased risk of developing type 2 diabetes (T2D), and this association persisted even among participants who maintained […]
March 6, 2024
Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]
March 6, 2024
Investigators have developed a model to assess the risk for outdoor falls in snowy and icy winter conditions. The model considers ice, snow on the ground […]
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