FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing Exelixis Cabometyx ...
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.
FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods used to evaluate bi...
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly repo...
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improve...
