Tag: drug approval
Semaglutide Approved for Advanced Liver Disease: First GLP-1 Drug to Treat MASH with Fibrosis
Semaglutide (Wegovy) has become the first glucagon-like peptide-1 receptor agonist approved to treat metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver…
UK’s MHRA Publishes Performance Data: Drug Approvals, Review Times, and Regulatory Efficiency Metrics
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published comprehensive performance data on drug approvals, review timelines, and…
UK and US Regulators Launch Joint Liaison Programme to Strengthen Drug Approval Coordination
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) have launched a formal…
FDA’s Pazdur Calls for Agency Restructuring Amid China Competition and Internal Upheaval
FDA's Rick Pazdur calls for fundamental agency restructuring following internal disruption, citing China competition as key driver for reform. Speaking…
MHRA Grants Marketing Authorisations to 47 New Medicines in 2026
MHRA granted marketing authorisations to 47 new pharmaceutical products in 2026. The approvals reflect continued pharmaceutical innovation and UK regulatory…
EU and US Drug Regulators Split Over AstraZeneca’s New Breast Cancer Treatment
European and American drug regulators reached opposing conclusions on AstraZeneca's experimental breast cancer treatment. The EMA endorsed the antibody-drug conjugate…