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Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used as a treatment for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. [ 2 ] [ 5 ] Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate.
United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014), [1] was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The approval opens up a wide market of patients for Lilly at a time when demand for Zepbound is already surging. Lilly's weight-loss treatment Zepbound becomes first FDA-approved drug for sleep ...
The weight loss drug Zepbound, generically known as tirzepatide, is also now an approved medication to treat obstructive sleep apnea, per a Food and Drug Administration Dec. 20 press release.
The FDA approval was based on a clinical trial of 372 participants with relapsed mycosis fungoides or Sézary syndrome who received either mogamulizumab or a type of chemotherapy called vorinostat. The FDA granted the application for mogamulizumab priority review, breakthrough therapy , and orphan drug designations.
In April 2019, erdafitinib was granted approval by the US Food and Drug Administration (FDA) for treatment of metastatic or locally advanced bladder cancer with an FGFR3 or FGFR2 alteration that has progressed beyond traditional platinum-based therapies, subject to a confirmatory trial.
It’s FDA-approved to help people with type 2 diabetes manage their blood sugar levels. It’s also often prescribed off-label for weight loss. ... A 2023 systematic review looked at 10 studies ...