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
FDA Approval
FDA Approval
05/25/2026
Anthony Calabro, MA
The FDA approved Baxfendy as an adjunctive treatment to lower blood pressure in adults with hypertension not adequately controlled on other antihypertensive medications.
05/25/2026
FDA Alert
FDA Alert
12/23/2025
Anthony Calabro, MA
The FDA has cleared a once-daily oral semaglutide treatment for adults with obesity or overweight and weight-related conditions, based on phase 3 OASIS 4 trial results demonstrating significant mean weight...
12/23/2025
FDA Alert
FDA Alert
01/28/2025
Anthony Calabro, MA
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...
01/28/2025
FDA Alert
FDA Alert
03/21/2024

Anthony Calabro, MA

Anthony Calabro, MA
On March 8, the FDA approved the injectable weight loss medication, semaglutide, for reducing the risk of cardiovascular events such as heart attack, stroke, and cardiovascular death in adults with heart...
03/21/2024
cardiovascular disease
cardiovascular disease
06/06/2017
The US Food and Drug Administration has expanded the approval of the Sapien 3 Transcatheter Heart Valve.
06/06/2017