FDA clears an EBM Technologies 510(k) for its iPad Pro-based Rad System for diagnostic reading of radiological images.
Omeros says it has reached agreement with FDA on a Phase 3 clinical trial plan for the companys OMS721 to treat immunoglobulin A nephropathy.
FDA issues a final guidance on coordination of development and review of antimicrobial drugs with antimicrobial susceptibility tests.
Management researchers suggest a more flexible approach to FDA drug review and evaluation.
FDA says it is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and pac...
FDA issues Actelion Pharmaceuticals a complete response letter for its supplemental NDA for Opsumit (macitentan) for treating adults with inoperable c...
FDA approves a Nexus Pharmaceuticals ANDA for busulfan injection, the companys AP-rated therapeutic equivalent to Otsukas Busulfex 60 mg/10 mL (6 mg/1...
FDA releases two models of drug facts labeling companies can use to speed applications for OTC naloxone.