Hikma Pharmaceuticals gains approval from FDA for its icosapent ethyl capsules, 1 gm, the generic equivalent of Amarin Pharmaceuticals Vascepa.
FDA approves Sunovions Kynmobi for Parkinsons disease off-time use.
FDA approves a Takeda Pharmaceutical Company NDA for Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-...
Federal Register notice: FDA makes available guidance documents related to the Covid-19 (XXX U/lc XXX) public health emergency.
FDA approves a Chiesi Global Rare Diseases NDA for Ferriprox (deferiprone) twice-a-day tablets for treating patients with transfusional iron overload ...
A CDRH Webinar explains which medical device manufacturers are required to notify FDA of a permanent discontinuance or interruption in the supply of c...
CBER cautions ValeoMD that it is marketing a human cell, tissue, or cellular or tissue-based product without the necessary BLA or IND.
FDA issues an RFI for a contractor to deploy artificial intelligence-based capabilities to support CDER drug product assessments and business operatio...