The FDA has reaffirmed its position that elevated LDL is a risk factor for heart attack, stroke, and sudden death, among other cardiovascular diseases, and that reducing LDL levels lowers the risk of these diseases.
The FDA has accepted an investigational new drug (IND) application from Medarex, Inc., for MDX-1203, the company’s first antibody-drug conjugate (ADC). The ADC is made of a potent cytotoxic prodrug chemically linked with an anti-CD70 antibody.
Abbott Laboratories, in Abbott Park, Ill., has received approval of Trilipix (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL and raise HDL in patients with lipid problems.
The FDA has announced new recommendations on evaluating cardiovascular (CV) risk of drugs intended to treat type 2 diabetes, asking manufacturers to provide evidence that the therapy will not increase the risk of heart attacks and other events.