The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Source:…

Hacker groups in Russia and North Korea continue to mount cyberattacks against companies working on COVID-19 vaccines and treatments, Microsoft warned, calling on governments to take action against them. Source:…

Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., drew a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Source:…

An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Source: Drug GMP Report

UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Source: Drug GMP Report

Pro Breath MD and Vibrant Health Care: The FDA has issued a flood of warning letters during the pandemic to crack down on marketers of sham COVID-19 treatments. Source: Drug…

The FDA published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Source: Drug GMP Report

The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved…