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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
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.
