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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]
A new policy analysis from the Cato Institute urges FDA to modernize its regulatory framework for artificial intelligence in healt...[ 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...[ Price : $8.95]
FDA cites an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspectio...[ Price : $8.95]
FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBERs next director.