New Immunotherapy Combination Granted FDA Approval for Certain Adults with Multiple Myeloma
November 7th 2018Officials with the FDA have approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone for the treatment of certain patients with relapsed or refractory multiple myeloma.
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FDA Grants Priority Review for Dupilumab as Potential Treatment for Atopic Dermatitis in Adolescents
November 6th 2018The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients aged 12 to 17 years with moderate-to-severe atopic dermatitis.
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FDA Grants Accelerated Approval to Lorlatinib for ALK+ NSCLC
November 4th 2018The FDA has granted lorlatinib (Lorbrena) an accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on 1 or more ALK tyrosine kinase inhibitors.
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FDA Approves Pegfilgrastim Biosimilar for Patients Receiving Myelosuppressive Chemotherapy
November 3rd 2018Officials with the FDA have approved Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).
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