December 13, 2024
The European Medicines Agency (EMA) has recommended that a new oral agent, Welireg (belzutifan), be granted conditional marketing authorization for treatment of two different diseases: the […]
December 13, 2024
The European Medicines Agency (EMA) has recommended extending the use of Ofev (nintedanib) to include treating progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents […]
December 13, 2024
The European Medicines Agency (EMA) has recommended granting marketing authorization for Seladelpar Gilead (seladelpar lysine dihydrate) to treat primary biliary cholangitis (PBC). PBC is a chronic […]
December 13, 2024
LOS ANGELES — The median cost of brand-name anti-seizure medications (ASMs) in the United States almost doubled from 2013 to 2023, whereas generic ASM prices declined […]
December 13, 2024
Podcast Dr. Weber: Welcome to the CDER Small Business and Industry Assistance, or SBIA, Chronicles Podcast. Today’s topic: Improving Data Quality with Centralized Statistical Monitoring My […]
December 13, 2024
Docket Number: FDA-2018-D-1216 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides detailed information and specifications for the content of the […]
December 13, 2024
SAN ANTONIO — For patients with so-called “good-risk” ductal carcinoma in situ (DCIS) who did not have radiation therapy after breast-conserving surgery, adjuvant tamoxifen reduced their […]
December 13, 2024
TOPLINE: The initiation of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), particularly rituximab and abatacept, is associated with an increased risk for incident cancer in […]
December 13, 2024
TOPLINE: Indoor tanning exposure was not associated with tumor mutational burden (TMB) in patients with cutaneous melanoma, in a retrospective cohort study. Higher TMB was linked […]
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