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XTL granted orphan drug designation for multiple myeloma treatment
HERZLIYA, Israel — The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.
XTL announced that the FDA had granted the designation to its recombinant human erythropoietin, or rHuEPO drug, for which the company soon will start phase-2 clinical trials.
The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States per year.
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Solesta approved by FDA as fecal incontinence treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved an injectable gel for fecal incontinence, the agency said.
The FDA announced the approval of Oceana Therapeutics’ Solesta for patients who have involuntarily lost bowel control and for whom such therapies as diet change, fiber therapy and antimotility medications have failed.
Fecal incontinence affects more than 5.5 million Americans, according to the National Institutes of Health.