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 […]
March 1, 2023
Eli Lilly will cut prices for most of its insulins in the US by 70% and cap out-of-pocket costs for insulin at $35 per month, the […]
February 27, 2023
There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the US Food […]
February 24, 2023
The US Food and Drug Administration (FDA) has approved efanesoctocog alfa (Altuviiio), a first-in-class, high-sustained factor VIII replacement therapy for adults and children with hemophilia A. […]
February 21, 2023
The European Commission has granted conditional marketing authorization for etranacogene dezaparvovec (Hemgenix), the first and only one-time gene therapy for the treatment of severe and moderately […]
February 20, 2023
The US Food and Drug Administration (FDA) gave accelerated approval on February 17 to sparsentan (Filspari), the first non-immunosuppressive therapy labeled for treating adults with primary […]