Anna Bratulic

Eli Lilly unveiled new data Monday that it says raises the prospect of a one-and-done cholesterol-lowering treatment for certain patients at high cardiovascular risk. In updated interim results from the Phase Ib Heart-2 study, presented at the European Atherosclerosis Society (EAS) congress, the company reported that its in vivo PCSK9 base-editing therapy VERVE-102 reduced levels of the target protein by up to 88% and cut LDL cholesterol (LDL-C) by as much as 62%.

The FDA on Friday approved AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor therapy, giving the TROP-2-directed antibody-drug conjugate (ADC) its second breast cancer approval in the US.

The leadership tumult at the FDA may soon see the departure of yet another high-ranking official. Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research (CDER), is expected to leave the agency just days after Commissioner Marty Makary tendered his resignation, according to a Reuters report Friday citing three unnamed sources.