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FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editin...[ Price : $8.95]
Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing...[ Price : $8.95]
Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.[ Price : $8.95]
FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys...[ Price : $8.95]
FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.[ Price : $8.95]
FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods...[ Price : $8.95]
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requireme...[ Price : $8.95]
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development wi...