Timelines
Notable FDA Approvals
Timelines
07/27/2026
July 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
07/27/2026
FDA APPROVAL
FDA APPROVAL
07/16/2026
Anthony Calabro, MA
The FDA approval provides physicians with a once-daily oral PCSK9 inhibitor option to reduce LDL-C in adults with high cholesterol, including those with heterozygous familial hypercholesterolemia.
07/16/2026
Cholesterol
Cholesterol
02/24/2020
The FDA has approved a new agent for lowering LDL-C in adults with heterozygous familial hypercholesterolemia or established ASCVD as an adjunct to diet and maximally tolerated statin therapy.
02/24/2020
Cholesterol
Cholesterol
06/10/2015
An FDA advisory committee has voted to recommend approval of a new drug for the long-term treatment of patients with hypercholesterolemia and dyslipidemia.
06/10/2015