The Pharmacy Times® Pharmacy Hospital Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to hospital and health-system pharmacists.
January 29th 2025
This marks the first US biologic license application filing acceptance for a biosimilar candidate to golimumab.
Updates on 503A Compounding: Legal and Regulatory Developments
April 7th 2023Part 1 of this 2-part series examines USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA.
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Accelerated Approvals Withdrawn for Ibrutinib in Mantle Cell Lymphoma, Marginal Zone Lymphoma
April 7th 2023Accelerated approvals for ibrutinib (Imbruvica) for patients with mantle cell lymphoma and with marginal zone lymphoma voluntarily withdrawn based on data that were insufficient to support conversion to full approval.
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FDA Accepts Supplemental New Drug Application for Encorafenib, Binimetinib Combination in NSCLC
April 6th 2023The application is based on the PHAROS trial, which met its primary endpoint of objective response rate in patients with metastatic non–small cell lung cancer with a BRAF V600E mutation.
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