FDA issues scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overlo...
FDA approves Genentechs Avastin (bevacizumab) for use in combination with chemotherapy, followed by Avastin as a single agent, for treating women with...
FDA approves a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion.
FDA accepts for review a Sunovion NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people li...
Federal Register notice: FDA makes available a draft guidance entitled Limited Population Pathway for Antibacterial and Antifungal Drugs.
FDA clears a Gold Standard Diagnostics 510(k) for its Borrelia burgdorferi IgG/IgM ELISA Lyme assay.
FDA and generic drug industry representatives shared insights on threats to the industry and elements of the GDUFA 2 commitment letter during an imple...
FDA reports to Congress on its activities to implement a Cures Act requirement for mandatory staff training on medical device least burdensome princip...