FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under age 5.
Covis Pharma says it is willing to work with CDER on an orderly withdrawal of Makena from the market.
Six Oncology Center of Excellence staff members describe the process used in developing a new patient-focused glossary of cancer clinical trial terms.
The United States Pharmacopeia launches its Nitrosamines Analytical Hub to help address the nitrosamine crisis in the U.S.
FDA annual inspection metrics from its Bioresearch Monitoring program show that the most common clinical investigator inspectional observations involv...
FDA grants Quidel a de novo marketing authorization for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, which is the first tes...
Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.
Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due to safety or effectiv...
