FDA launches a generative Artificial Intelligence tool called Elsa that is designed to help employees from scientific reviewers to investigators wor...
Congressman Jason Crow (D-CO) leads a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrophic Lateral Sclerosi...
A new combination therapy involving AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentechs Perjeta) shows signifi...
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FDA releases a draft guidance entitled M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.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...
