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Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in people unable to tolerate UDCA [2] Epkinly: Treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy [2] Fidanacogene ...
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
In order to qualify for RMAT status, a treatment must meet the definition of a regenerative medicine therapy, intend to treat, modify, reverse or cure a serious condition, and; be supported by preliminary clinical evidence that indicates the RMAT candidate can address the clinical need. [4]
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Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions. Breakthrough Therapy Designation requires preliminary clinical evidence suggesting a candidate may provide substantial improvement over available ...
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Scientists have developed a new treatment that may help regenerate myelin around nerve cells, and potentially reverse the damage caused by multiple sclerosis (MS).
In March 2017, ocrelizumab was approved in the United States for the treatment of primary progressive multiple sclerosis in adults. [22] [42] It is also used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. [42]