March 6, 2024
OSI Metrics Overview | FDA In this section: Center for Drug Evaluation and Research | CDER Home About FDA FDA Organization Center for Drug Evaluation and […]
March 6, 2024
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive […]
March 6, 2024
An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a […]
March 6, 2024
TOPLINE: Sex-specific differences in kidney metabolism may underlie differences in diabetic kidney disease (DKD) outcomes in men and women, new research suggests. METHODOLOGY: To identify sex-based […]
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) […]
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