FDA releases its FY 2026 budget proposal showing that the agencys overall budget would decrease by 4% ($271 million) to $6.8 billion beginning 10/1.
FDA approves Modernas next-generation Covid-19 vaccine, Nexspike (mRNA-1283), for use in all adults 65 and older, and individuals aged 12-64 years wit...
A federal appeals court upholds a freeze on layoffs across FDA and other major federal agencies, rejecting an effort by the Trump administration to li...
FDA clears a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system.
FDA launches a generative Artificial Intelligence tool called Elsa that is designed to help employees from scientific reviewers to investigators wor...
FDA releases a draft guidance entitled M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.
FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP defic...
Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because they are allegedly l...
