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FDA grants Quidel a de novo marketing authorization for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, wh...[ Price : $8.95]
Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.[ Price : $8.95]
Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due t...[ Price : $8.95]
FDA extends to 6/30 the PDUFA action date for BioMarins Roctavian gene therapy for adults with severe hemophilia A.[ Price : $8.95]
An FDA Clinical Pharmacology Corner post highlights four recent agency articles on aspects of its efforts to tackle the opioid epi...[ Price : $8.95]
FDA warns Thomas Advanced Medical about illegally marketing human cell and tissue products.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Fosun Pharma ANDA for pemoline tablets after the company requested it be with...[ Price : $8.95]
FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.