The sNDA is supported by data from the phase 3 EMPEROR-Reduced trial which compared the efficacy and safety of empagliflozin to placebo, in addition to recommended therapy, in 3730 patients with chronic heart failure with reduced ejection fraction.
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
So far, the therapies scheduled to be part of the trial are risankizumab, an interleukin-23 antagonist, and lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US.
Haymarket Medical Network, a part of business media company Haymarket Media, Inc., is proud to join the Ad Council’s first ever Private Marketplace (PMP) along with other partners Cadreon, The Trade Desk and Acxiom.
Horizon Therapeutics announced the availability of Procysbi (cysteamine bitartrate) delayed-release oral granules in tear-open packets for the treatment of nephropathic cystinosis in patients aged 1 year and older.
The use of telemedicine has been surging since the onset of coronavirus disease 2019 (COVID-19), with millions of Americans now using this medium for connecting with their clinicians, according to a report that appeared in Kaiser Health News.1 The increase in use of this modality can be attributed to fears of contracting COVID-19, social distancing…
The American Board of Internal Medicine (ABIM) announced that certified physicians who have a Maintenance of Certification (MOC) requirement due in 2020 will now have until the end of 2021 to complete it.
The FDA has approved a new version of Axonics Modulation’s rechargeable implantable sacral neurostimulator (r-SNM) system that allows patients to decrease the frequency of charging to once a month.
The Food and Drug Administration (FDA) has approved Nexletol (bempedoic acid; Esperion) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Nexletol is a first-in-class adenosine triphosphate-citrate lyase (ACL)…
