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Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due to safety or effectiv...
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.
Federal Register notice: FDA withdraws approval of a Fosun Pharma ANDA for pemoline tablets after the company requested it be withdrawn.
FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.
