Omeros and FDA agree to a response-based primary endpoint for its pivotal trial to support a BLA for narsoplimab to treat hematopoietic stem cell tran...
FDA accepts for review a Neurocrine Biosciences NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjuncti...
The Virginia U.S. Attorney outlines a $1.4 billion settlement with Reckitt Benckiser to resolve civil and criminal cases involving marketing of its Su...
FDA scientists develop and qualify a Tissue Mimicking Material for Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ult...
FDA says it has assessed all 28 European Union member states under the FDA/EU Mutual Recognition Agreement (MRA), which allows the agency to recognize...
A Washington Legal Foundation posts reviews a Pennsylvania case determining whether strict liability claims may be allowed for prescription medical de...
FDA issues two draft guidances aimed at speeding generic drug development and marketing.
Federal Register final rule: FDA issues a final rule to revise the animal drug regulations for new animal drug residue tolerances.