by Admin | Mar 23, 2026 | Regulatory Updates
MHRA approved deuruxolitinib for severe alopecia areata in adults and explicitly said it would continue to keep the medicine’s safety and effectiveness under close review. Meanwhile, EMA listed new ESMP training for industry and published continued CVMP activity for...
by Admin | Mar 23, 2026 | Inspections & Compliance, Regulatory Updates
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 serious risks identified through that system. Separately, FDA’s Drug Safety Communications page is updated with...
by Admin | Mar 23, 2026 | Careers, Regulatory Updates
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 therefore requested removal of that warning language from affected labels. The agency also points to a large...
by Admin | Mar 22, 2026 | Regulatory Updates
FDA announced action to restrict unlawful imports of xylazine active pharmaceutical ingredients and finished dosage-form drug products into the United States. The agency said xylazine has increasingly been found in illicit drugs, including illicitly manufactured...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing authorisation applications. While not a pharmacovigilance page, this kind of pathway guidance matters because...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA’s Safety Roundup: February 2026 pulls together recent medicines and device safety information, including semaglutide-associated NAION and falsified Mounjaro pens, into a single regulator-issued summary. That makes it more than a newsletter-style update. It is...
