by Admin | Mar 14, 2026 | News
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 as a precautionary measure because an impurity above the acceptable limit was identified. MHRA said the...
by Admin | Mar 14, 2026 | Safety Signals
The UK’s Medicines and Healthcare products Regulatory Agency has warned that some patients may have been dispensed fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens from The Private Pharmacy Clinic in Birmingham. MHRA said all affected fake pens identified so...
by Admin | Mar 14, 2026 | Safety Signals
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of a safety signal involving aseptic meningitis with Ixchiq, the live attenuated chikungunya vaccine. EMA said PRAC has recommended an update to the product information to reflect the...
by Admin | Mar 14, 2026 | Regulatory Updates
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). The agency stated that this added MRI should occur before the 3rd infusion, in addition to the monitoring...
by Admin | Mar 13, 2026 | Inspections & 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 company’s compliance with postmarketing adverse drug experience (PADE) regulations. According to the letter, the...
