by Admin | Apr 13, 2026 | Regulatory Updates
EMA published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) for 10–12 March 2026 and noted that the committee meeting was followed by EMA Veterinary Medicines Info Day 2026 on 12–13 March 2026, covering scientific, legislative, and...
by Admin | Apr 13, 2026 | Regulatory Updates
EMA’s March 2026 additional monitoring update says Anktiva was added to the list as a new active substance, new biological, and conditionally authorised product. EMA’s published list also records products removed from the list in the same update cycle. For PV readers,...
by Admin | Apr 13, 2026 | Regulatory Updates
MHRA and NICE announced a streamlined approval process intended to help patients in England receive some new medicines three to six months earlier. The agencies say the aligned pathway and an improved advice service are designed to support faster access and help...
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...
