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December 16, 2022

FDA Approves First Gene Therapy for Bladder Cancer FDA Approves First Gene Therapy for Bladder Cancer

The US Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer. The adenovirus vector based gene therapy […]
December 15, 2022

Capecitabine’s Label Updated Under FDA Project Renewal Initiative Capecitabine’s Label Updated Under FDA Project Renewal Initiative

Today, the US Food and Drug Administration approved several indications and other updates to the label of capecitabine tablets (Xeloda) under the agency’s Project Renewal initiative. […]
December 15, 2022

FDA Approves Idacio as Eighth Adalimumab Biosimilar in US FDA Approves Idacio as Eighth Adalimumab Biosimilar in US

A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in […]
December 13, 2022

ADA Advises New BP, Lipid Targets for People With Diabetes ADA Advises New BP, Lipid Targets for People With Diabetes

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes — […]
December 13, 2022

Adagrasib (Krazati) Approved for KRAS-Mutated NSCLC Adagrasib (Krazati) Approved for KRAS-Mutated NSCLC

The US Food and Drug Administration (FDA) has granted accelerated approval to adagrasib (Krazati) for use in adults with KRAS G12C-mutated locally advanced or metastatic non–small […]
December 9, 2022

FDA Clears Two Biomarker Assays for Early Alzheimer’s Detection FDA Clears Two Biomarker Assays for Early Alzheimer’s Detection

The US Food and Drug Administration (FDA) has approved two assays that reliably measure two biomarkers of Alzheimer’s disease (AD) in cerebrospinal fluid (CSF) — beta-amyloid […]
December 8, 2022

FDA OKs Bivalent COVID Shots for Children 6 Months and Older FDA OKs Bivalent COVID Shots for Children 6 Months and Older

The FDA on Thursday authorized bivalent COVID-19 vaccines for children as young as 6 months old who previously received the Moderna vaccine or who have not […]
December 8, 2022

FDA Okays Dexcom G7 Continuous Glucose Monitoring System FDA Okays Dexcom G7 Continuous Glucose Monitoring System

The US Food and Drug Administration (FDA) has cleared the Dexcom G7 continuous glucose monitoring (CGM) system for people with all types of diabetes aged 2 […]
December 6, 2022

FDA Issues Updated Safety Alert on Endologix AAA Repair Grafts FDA Issues Updated Safety Alert on Endologix AAA Repair Grafts

The US Food and Drug Administration (FDA) has issued an update to its January 2022 safety communication on the use of Endologix AFX endovascular grafts to […]
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