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Genentech’s Xeloda Is First Label Updated Under OCE’s ‘Project Renewal’

 
• By Kate Rawson

Capecitabine’s existing indications were revised and new indications added, reflecting uses that long have been considered standard of care; however, the cancer drug's label had been frozen in time since the approval of generics.

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No longer frozen in time, Xeloda's labeling has gotten some big changes. • Source: Shutterstock

The FDA’s Oncology Center of Excellence has completed the first “Project Renewal” update to the labeling of an older generic cancer drug with additional indications and dosing regimens for Genentech, Inc.’s Xeloda (capecitabine).

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

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Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
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US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
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