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 extends to 6/30 the PDUFA action date for BioMarins Roctavian gene therapy for adults with severe hemophilia A.
An FDA Clinical Pharmacology Corner post highlights four recent agency articles on aspects of its efforts to tackle the opioid epidemic.
FDA warns Thomas Advanced Medical about illegally marketing human cell and tissue products.
FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.
FDA announces a 3/30 workshop entitled Immune Globulin (IG) Hypersensitivity Reactions: Root Causes and Mitigation that is intended to address excessi...
