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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Healthcare Facilities Accreditation Program (HFAP) Healthcare Quality Association on Accreditation (HQAA) Institute for Medical Quality (IMQ) Joint Commission (TJC) National Committee for Quality Assurance (NCQA) National Dialysis Accreditation Commission (NDAC) [6] The Compliance Team, "Exemplary Provider Programs"
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 ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage.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.
A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. [2] RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints. A surrogate endpoint is a biomarker that substitutes for a direct endpoint, such as clinical benefit. [3]
The FDA approval in 2011 was based on two small prospective trials of 17 people and 20 people. [ 15 ] [ 8 ] [ 23 ] The European Medicines Agency approved it for the treatment of paroxysmal nocturnal hemoglobinuria in June 2007, [ 7 ] and in November 2011, for the treatment of atypical hemolytic uremic syndrome. [ 24 ]
The FDA has not approved ivermectin as a COVID-19 treatment because studies have not proven it is effective. Court revives doctors' lawsuit saying FDA overstepped its authority with anti ...
Alipogene tiparvovec (Glybera): AAV-based treatment for lipoprotein lipase deficiency (no longer commercially available); Axicabtagene ciloleucel (Yescarta): treatment for large B-cell lymphoma [1]