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...
Critics call out HHS secretary Robert F. Kennedy Jr.s recent Make America Healthy Again report for citing allegedly nonexistent scientific studies.
FDA releases a draft guidance entitled M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.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...
AstraZeneca and Handa Pharmaceuticals agree to pay $51.4 million to resolve allegations they participated in a pay-for-delay scheme to block generic S...
FDA grants BiVACOR a breakthrough device designation for its titanium Total Artificial Heart.
