CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in granting an emergency use...
Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.
FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease.
An FDA safety update indicates that an agency literature review has found reports of 19 squamous cell carcinoma cases in the scar tissue (capsule) are...
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.
