Tag: FDA

Consumer Health – USA/UK/Asia/ROW Regulatory News – Feb 2025

March 12, 2025
Consumer Health

USA Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate...

Consumer Health, FDA, February 2025, Food Regulations, Food Safety, Global Health Compliance, Health Updates, Product Safety, Regulatory News

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 5, 2025
Biopharma

USA FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class...

BioPharma, BioTech, Clinical Trials, Drug Approval, EMA, FDA, Healthcare Pharma Regulations, Pharma News, Regulatory Updates

Consumer Health – USA/Europe/Asia/ROW Regulatory News – Jan 2025

February 5, 2025
Consumer Health

USA FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods The U.S. Food and Drug Administration is announcing an important step to provide nutrition information...

Consumer Health, FDA, Food Safety, Global Health, Healthcare News, Medical Compliance, Nutrition Labels, Public Health, Regulatory Updates, Tobacco Regulations

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Biopharma

USA FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet...

Approval Healthcare Updates, Biotech News, Cancer Treatment, Drug Approval, FDA, Medical Advancements, Medicines, Patient Care, Pharma News, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Sept 2024

October 7, 2024
Biopharma

USA FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral...

Asia Regulations, Drug Approvals, EMA, Europe Pharma, FDA, Global Health, Safety Updates, USA Drug Updates