by Admin | Apr 13, 2026 | Inspections & Compliance
FDA announced on 3 March 2026 that it issued 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites. Separately, on 6 February 2026, FDA said it intended to take action against...
by Admin | Apr 13, 2026 | News
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 approved on 10 March 2026 to Sun Pharma UK Limited via the International Recognition Procedure. The agency says...
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 | Apr 13, 2026 | News
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of Saxenda, Wegovy, and Zepbound after a comprehensive review found no increased risk with GLP-1 receptor agonist use. FDA says its...
by Admin | Apr 13, 2026 | News
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 deficiency and vitamin B6 deficiency-associated seizures. The agency says the products are approved to treat...
