Akin Gump attorneys update FDA enforcement actions involving laboratory-developed tests.
FDA releases its latest batch of Warning Letters that includes one medical product company Petra Hygienic Systems.
FDA approves Regeneron Pharmaceuticals Eylea (aflibercept) injection to treat all stages of diabetic retinopathy.
Connecticut attorney general William Tong leads a 44-state lawsuit against Teva Pharmaceuticals and 19 generic drug manufacturers that alleges a broad...
FDA approves Abiomeds expanded use of its Impella 5.0 and Impella LD heart pumps for treating cardiogenic shock.
A New York Times article questions generic drug safety and quality, leading to a defensive post from CDER director Janet Woodcock about the agencys ov...
Federal Register notice: FDA determines the regulatory review period for W.L. Gore & Associates Gore Viabahn VBX Balloon Expandable Endoprosthesis.
Federal Register notice: FDA announces a 6/7 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Bios...