by Admin | Mar 23, 2026 | News
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 medicine, it will keep the safety and effectiveness of deuruxolitinib under close review. For PV readers, the...
by Admin | Mar 23, 2026 | News
FDA says it is requesting that drug application holders remove information regarding suicidal ideation and behavior from the labeling of certain GLP-1 receptor agonist medications, specifically Saxenda, Wegovy, and Zepbound. The agency says this follows a...
by Admin | Mar 22, 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...
by Admin | Mar 22, 2026 | Careers
EMA’s substance and product data management services guidance says marketing authorisation holders should verify that data submitted to XEVMPD or SIAMED displays correctly in PMS and consult the PMS FAQ and EU IDMP materials where needed. That shows PMS and related...
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...
