The PDUFA action date is May 10, 2024.
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Aphexda is expected to be available in September 2023.
Crovalimab is an investigational anti-complement 5 recycling monoclonal antibody.
During extended treatment, bleeding risk was similar for apixaban and rivaroxaban.
Overall median annualized bleeding rate was 0 with concizumab.
Lower treatment retention rates seen with 30-day, out-of-pocket costs $150 or greater.
The approval was based on data from the pivotal phase 3 COMMANDS trial that compared luspatercept to epoetin alfa in 356 patients with anemia and lower-risk MDS.
Imetelsat is an investigational first-in-class telomerase inhibitor.
Balfaxar is a non-activated 4 factor prothrombin complex concentrate containing vitamin K-dependent factors.
The safety, tolerability, and immunogenicity of STAR-0215 is being evaluated in the ALPHA-STAR clinical trial.
Study findings suggest clinicians may safely prescribe alpha blockers to help manage hypertension in patients receiving hemodialysis.
Endo’s product is the only ready-to-use formulation of bivalirudin currently on the market.
Ryplazim works by temporarily increasing plasminogen levels in blood.
Roctavian is the first gene therapy approved for severe hemophilia A.
A regulatory decision is expected in the second quarter of 2024.
Risk for anemia incidence and decline in ferritin greater for seniors receiving low-dose aspirin.
No improvement seen in favorable functional outcome at 6 months, but reduced risk of death at 28 days after injury.