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PRAC recommendations on signals adopted at the  6-9 July 2026 PRAC meeting

August 11, 2026

Product information updates for desogestrel/etonogestrel and meningioma, levonorgestrel intrauterine systems and ectopic pregnancy, and information concerning atogepant and insomnia, CGRP antagonists and Raynaud's phenomenon, oseltamivir safety in critically ill patients, sacituzumab govitecan and interstitial lung disease, selpercatinib and intestinal lymphangiectasia, and sevoflurane and acute encephalopathy in patients carrying the mitochondrial DNA variant m.11232T>C.

Gastrointestinal Drug Safety in 2025: A Comprehensive Review of Major Regulatory Warnings and Updates

June 23, 2026

The year 2025 witnessed significant regulatory actions affecting the safety profiles of multiple gastrointestinal drug classes. From the persistent concerns surrounding PPIs and the emerging risks of GLP-1 receptor agonists, to the serious gastrointestinal toxicities of CAR-T therapy and the cardiac risks of loperamide overuse, the regulatory landscape for GI drugs continues to...

The EPVC Newsletter (Volume 20, Issue 4- April 2026)

May 26, 2026

Regulatory update on isotretinoin prescribing requirements, a detailed local case safety report documenting posterior reversible encephalopathy syndrome (PRES) in two pediatric oncology patients receiving cyclophosphamide-containing chemotherapy.

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