FDA reminds healthcare professionals working in surgical settings of the risk of surgical fires that can injure patients.
FDA issues a guidance to assist in developing drugs to treat complicated intra-abdominal infections.
FDA Review posts the Federal Register notices for the week ending 5/25/2018.
FDA Review posts product approval summaries for the week ending 5/25/2018.
FDA approves a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria, a rare and serious genetic disease.
FDA clears a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the ...
FDA grants Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to detect w...
FDA grants Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa.