FDA Declines to Review Modernas mRNA-1010 Flu Vaccine Application, Citing Comparator Concerns The FDAs Center for Biologics Evaluation and Research (CBER) has declined to review Modernas biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and issued a refusal-to-file (RTF) letter, according to an announcement released by the company
Supply chain concentration risk also remains a meaningful concern
This metabolic shift forces the body to enter a state called ketosis , where it burns fat for fuel instead of glucose, producing ketone bodies as an alternative energy source
From case reports of severe inflammation and liver injury, to regulatory alerts about contamination the hazards outweigh the unproven benefits
Semaglutide , an active ingredient found in both Ozempic and Wegovy, is primarily used in managing type 2 diabetes and weight loss in adults, with each brand targeting different aspects of treatment
Clinical trials have proven its efficiency in significantly controlling weight by reducing appetite
