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Luspatercept is indicated for the treatment of adults with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
Luspatercept is a TGFβ ligand that acts to decrease SMAD2 and SMAD3 signaling involved in erythropoeisis and may be used in MDS with anemia that is not responsive to erythrocyte stimulating agents or mild MDS with ring sideroblasts. Luspatercept was shown to decrease the need for transfusions and this effect lasted for a median of 30.6 weeks.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
Acceleron Pharma, Inc. is an American clinical stage biopharmaceutical company based in Cambridge, Massachusetts with a broad focus on developing medicines that regulate the transforming growth factor beta (TGF-β) superfamily of proteins, which play fundamental roles in the growth and repair of cells and tissues such as red blood cells, muscle, bone, and blood vessels.
On 28 April 2017, midostaurin was approved by the FDA for the treatment of adult patients with newly diagnosed AML who are positive for oncogenic FLT3, in combination with chemotherapy. [6] The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with ...
Elivaldogene autotemcel has a black box warning for hematological cancers, as patients have developed myelodysplastic syndrome (MDS) due to lentiviral integration into proto-oncogenes. [ 19 ] [ 20 ] Patients must be monitored with a complete blood count once every six months for fifteen years after treatment for evidence of MDS.
Miami Dolphins wide receiver Jaylen Waddle suffered a knee injury in the second quarter against the Houston Texans in Week 15.. The star receiver exited the game and entered the blue medical tent ...
In June 2001, it had been approved by the European Medicines Agency for this indication as well as the treatment of anemia in cancer patients undergoing chemotherapy. [5] Dr. Reddy's Laboratories launched darbepoetin alfa in India under the brand name Cresp in August 2010. This is the world's first follow-on biologic of darbepoetin alfa.