PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA says its comprehensive review of available data did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA medications and...
EMA’s PMS FAQs Show Where Product Data Friction Still Exists
EMA’s Product Management Service FAQs, updated in January 2026, collect questions raised during PMS events and are intended to complement those sessions. EMA...
FDA Approves Wegovy HD in 54 Days Under Priority Voucher Pilot
FDA announced on 19 March 2026 that it approved Wegovy HD (semaglutide 7.2 mg) for weight loss and long-term weight maintenance in certain adults. The agency...
What EMA’s 2026 Biologics Safety Page Signals About Ongoing Regulator Transparency
FDA’s 2026 Safety and Availability Communications page for biologics says it was developed to provide the public with important information about the safety...
Why Real-Time Safety Visibility Is Becoming a Regulatory Strategy
FDA says AEMS is its new Adverse Event Monitoring System, and the agency also maintains a dedicated page for new safety information or potential signals of...
What the GLP-1 Label Change Says About How Safety Evidence Can De-Escalate
FDA says its comprehensive review of available data did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA medications and...
CVMP March 2026 Meeting Highlights Keep Veterinary Safety on the Radar
EMA published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) for 10–12 March 2026. The agency says the meeting was followed by...
EMA Pushes ESMP Training as Shortage Reporting Matures
EMA’s “What’s new” page lists a new event for European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry dated 20...
MHRA Approves Deuruxolitinib for Severe Alopecia Areata
MHRA announced on 12 March 2026 that it approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults. The agency also stated that, as with any...
FDA Requests Removal of Suicidal Ideation Warning From GLP-1 Labels
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of certain GLP-1...