FDA approves Astellas Pharmas Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute myeloid leukemia (AML) ...
FDA grants six-month pediatric exclusivity to Pfizers Lyrica based on its use in pediatric epilepsy studies.
The International Council for Harmonization approves concept papers and business plans for three new informal working groups and a discussion group.
FDA clears a Mesa Biotech 510(k) for its Accula RSV test, a respiratory syncytial test cassette for diagnosing both children and adult populations.
FDA classifies as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA/W) Implantable Spin...
FDA approves Bayer and Loxo Oncologys Vitrakvi (larotrectinib) for treating adult and pediatric cancers in patients who have a specific genetic featur...
Former FDA associate commissioner Peter Lurie says FDA may have to lower its medical device approval standards if it wants to be the first to approve ...
FDA says it is lowering the minimum measles antibody potency specification for immune globulin products.