Turalio: USFDA approval of first therapy for rare joint tumor
U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell... Read More
Case Study: Pfizer’s BESPONSA® (inotuzumab ozogamicin) – drug development to U.S. FDA Approval
Brand Name: BESPONSA® Company: Pfizer Molecule: Inotuzumab ozogamicin Approved Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia... Read More
USFDA approves 3rd biosimilar: Erelzi, a biosimilar to Enbrel
Posted on02 Sep 2016
TagsBiosimilar, biosimilar of enbrel, black box warning, Erelzi, Etanercept, meaning of black box warning
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The U.S. Food and Drug Administration today approved Erelzi, for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally... Read More
What is the significance of Black Box Warning?
Posted on29 Nov 2014
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A black box warning is the sternest warning by the U.S. Food and Drug Administration (FDA) that a medication can carry and... Read More