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
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
