mFlusiva becomes the first mRNA influenza vaccine approved by the FDA
1. The FLUENT trial demonstrated 26.6% relative vaccine efficacy over a standard-dose comparator in adults 50 and older, clearing the ...
Tag: FDA approval
FDA Advisory Committee Votes Unanimously to Recommend Moderna’s mRNA Flu Vaccine
1. The FDA's top vaccine advisory committee voted 9-0 on June 18, 2026 to recommend Moderna's mRNA influenza vaccine mFlusiva ...
Orforglipron (Foundayo) expands oral treatment options for weight management
1. Orforglipron (Foundayo) introduces a new oral glucagon-like peptide-1 (GLP-1) receptor agonist that can be taken without food or timing ...
Sparsentan (Filspari) becomes first approved treatment for focal segmental glomerulosclerosis
1. Sparsentan (Filspari) becomes the first approved treatment specifically for focal segmental glomerulosclerosis. 2. Clinical trial data show meaningful reductions ...
Approved label populations may be broader than trial populations for new drugs
1. In this cross-sectional study, approved label populations were broader overall compared to trial populations for new drugs in the ...
The majority of FDA-approved drug trials recruit from low- and middle-income countries
1. This study found that a high proportion of Food and Drug Administration (FDA) drug trials recruit participants from low- ...
