The narrow FDA labeling makes it so that only a minority of men who could benefit from treatment are considered ‘on-label’ ...
The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...
MedPage Today on MSN
Expand labeling for testosterone replacement therapy, FDA panel says
Members of an FDA expert panel urged the agency to expand labeling for testosterone replacement therapy and remove its ...
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Nasal spray sold nationwide recalled due to mold, ‘life-threatening' infections possible, FDA says
The voluntary recall of ReBoost Nasal Spray was issued Wednesday by MediNatura New Mexico, according to an announcement from ...
An FDA panel pushes reclassify testosterone therapy by recommending removal of controlled substance status and expanding treatment eligibility.
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The FDA has restricted the type ...
Planned acquisition of brelovitug for chronic hepatitis delta virus (HDV) with Breakthrough Therapy and PRIME ...
Alert FDA Approves Third-Ever Drug for Lupus Nephritis Obinutuzumab (Gazyva) is the first drug to be approved for lupus nephritis since the approvals of belimumab (Benlysta) in 2020 and voclosporin ...
Alert Rejected cGvHD Therapy Gets Second Look by EMA The EMA initially rejected Rezurock due to uncertainty over its clinical benefit, noting that the pivotal study had no comparator arm and permitted ...
Microdosing GLP-1 weight loss drugs like semaglutide is trendy, with supporters touting benefits such as lower costs and potentially fewer side effects. But some doctors are skeptical, calling it ...
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