March 23, 2023
Ascend Laboratories LLC is recalling 10 lots of the oral anticoagulant dabigatran etexilate capsules (75 mg and 150 mg) because of unacceptable levels of a potential […]
March 22, 2023
The US Food and Drug Administration has expanded the indicated age range for evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals), which was approved 2 years ago as an adjunct to […]
March 22, 2023
The US Food and Drug Administration (FDA) has approved retifanlimab-dlwr (Zynyz), an intravenous programmed death receptor–1 (PD-1) inhibitor, for the treatment of adults with metastatic or […]
March 14, 2023
The US Food and Drug Administration (FDA) has approved zavegepant (Zavzpret, Pfizer), the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment […]
March 14, 2023
The US Food and Drug Administration (FDA) has approved trofinetide oral solution (Daybue, Acadia Pharmaceuticals) as the first treatment of Rett syndrome in adults and children […]
March 9, 2023
The US Food and Drug Administration (FDA) has made changes to existing mammography regulations. A final rule, updating the regulations issued under the Mammography Quality Standards […]
March 7, 2023
Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the US Food and Drug Administration (FDA). On March […]
March 1, 2023
The US Food and Drug Administration (FDA) has declined to approve omecamtiv mecarbil (Cytokinetics) for treatment of adults with chronic heart failure with reduced ejection fraction […]
March 1, 2023
The US Food and Drug Administration (FDA) approved sarilumab (Kevzara) today for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response […]