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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FDA Grants Approval to 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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Sufentanil Sublingual Tablet (Dsuvia) Gets FDA Approval
November 3rd 2018The approval is based on data from a multicenter trial in which patients were randomized 2:1 to receive either 30 mcg of the sufentanil sublingual tablet as needed, or placebo, with treatment limited up to 48 hours following the procedure.
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