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FDA Grants Fast Track Designation to Polycythemia Vera Treatment
The drug, 9MW3011, is also approved for clinical study by NMPA.
Mabwell announced that its polycythemia vera treatment has been granted fast track designation by FDA.
The designation expedites the review process and can help get valuable new treatments to patients at a faster pace.
In a press release, Mabwell noted that 9MW3011 has also been approved for clinical study in China by NMPA, and the first patient to receive a dose in a clinical study occurred in March 2023.
The drug inhibits the absorption and release of iron, lowers sodium levels, and can upregulate the level of hepcidin expressed by hepatocytes.
Source
(Sept. 22, 2023); Mabwell; FDA Grants Fast Track Designation to 9MW3011; https://mabwell.com/en/news_info/id-116.html
Beyond the Birthrate: The Societal Costs of Maternal Mortality
September 6th 2024Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
