FDA issues a draft guidance to update Section V of a 2008 CLIA Waiver guidance.
Teva Pharmaceuticals recalls all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets due...
The Justice Department says the former Insys Therapeutics vice president for sales pleaded guilty to one count of racketeering conspiracy for bribing ...
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...