PV Watch Daily Blog
Fresh reporting, analysis, and expert insight on drug safety, regulatory developments, safety signals, inspections, AI in pharmacovigilance, and career trends.
Why AI Governance Is Becoming a Career Advantage in Pharmacovigilance
There is growing excitement around AI in pharmacovigilance, but one career lesson is becoming clearer: in regulated environments, tool familiarity is not...
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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...
MHRA Announces Bayer Recall Over Impurity Above Acceptable Limit
MHRA has published a Class 3 Medicines Recall for Bayer Plc, various products, EL(26)A/12. The agency said Bayer is recalling all stock of the listed products...
MHRA Warns Patients About Fake Mounjaro KwikPen 15mg Pens
The UK’s Medicines and Healthcare products Regulatory Agency has warned that some patients may have been dispensed fake Mounjaro (tirzepatide) KwikPen 15mg...
EMA PRAC Warns About Aseptic Meningitis Risk with Ixchiq Vaccine
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of a safety signal involving aseptic meningitis with Ixchiq, the live...
FDA Recommends Earlier MRI Monitoring for Patients Taking Leqembi
The U.S. Food and Drug Administration has said it is recommending an additional, earlier MRI for patients with Alzheimer’s disease taking Leqembi (lecanemab)....
FDA Warning Letter to Novo Nordisk: What the March 2026 Action Signals for PV Compliance
On 5 March 2026, the FDA issued a warning letter to Novo Nordisk Inc. describing objectionable conditions observed during an inspection that reviewed the...
EMA’s PRAC Recommends Withdrawal of Levamisole Medicines: A Reminder of How Safety Reviews Can End
In February 2026, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded its safety review of levamisole-containing...