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...
CTIS Sponsor Training in June 2026 Signals the Growing Importance of Trial-System Skills
EMA has scheduled a CTIS sponsor end-user training programme for 8–11 June 2026. The event listing places the training firmly within the live operational...
EMA’s ESMP Training Push Signals More Structured Shortage Reporting
EMA’s upcoming events page lists European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry on 14 April 2026. EMA...
EMA Adds Anktiva to Additional Monitoring List in March 2026
EMA’s March 2026 additional monitoring update says Anktiva was added to the list as a new active substance, new biological, and conditionally authorised...
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. MHRA also notes that the medicine was...
MHRA and NICE Launch Faster Joint Approval Pathway
MHRA and NICE announced a streamlined approval process intended to help patients in England receive some new medicines three to six months earlier. The...
FDA Requests Removal of Suicidal Ideation Warning From Certain GLP-1 Labels
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of Saxenda, Wegovy, and...
FDA Requires Vitamin B6 Deficiency Warning for Carbidopa/Levodopa
FDA says it is requiring application holders for all drug products containing carbidopa/levodopa to add a warning that these medicines can cause vitamin B6...
Why MHRA’s Weekly Field Safety Notices Still Matter for Safety Monitoring
MHRA published Field Safety Notices: 9–13 March 2026 on 17 March 2026, listing device-related notices within its alerts, recalls, and safety-information...
Ramipril Recall After Packaging Error Raises Medication Mix-Up Risk
MHRA said Crescent Pharma Limited is recalling one batch of Ramipril 5 mg Capsules as a precautionary measure after a potential manufacturing error may have...