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Tag: Drug Approvals

Kanuma (sebelipase alfa) has been approved by the U.S. Food and Drug Administration as the first treatment for LAL deficiency (Wolman disease or cholesteryl ester storage disease).

FDA Approves Kanuma for Lysosomal Acid Lipase Deficiency

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For treatment of LAL deficiency, also known as Wolman disease or cholesteryl ester storage disease
Vonvendi has been approved by the U.S. Food and Drug Administration to treat adults with von Willebrand disease.

FDA Approves Vonvendi to Treat von Willebrand Disease

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Approved for the as-needed treatment and control of bleeding episodes in adults
The first seasonal influenza vaccine with an adjuvant has been approved for use in seniors

FDA Approves First Flu Vaccine Containing an Adjuvant

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Adjuvant can enhance or direct the immune response of the vaccinated individual
Empliciti (elotuzumab)

FDA Approves Empliciti for Multiple Myeloma

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Monoclonal antibody works with another approved therapy to provide additional benefit
Portrazza (necitumumab)

FDA Approves Portrazza for Advanced Squamous NSCLC

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Drug is designed to block activity of epidermal growth factor receptor protein
U.S. Food and Drug Administration approval for the BioThrax anthrax vaccine has been expanded to include adults aged 18 to 65 with known or suspected exposure

FDA Expands Anthrax Vaccine Approval

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Now sanctioned for adults 18 to 65 with known or suspected exposure
Opdivo (nivolumab) has been approved by the U.S. Food and Drug Administration to treat advanced renal cell carcinoma.

FDA Approves Opdivo for Advanced Renal Cell Carcinoma

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Drug works by targeting the PD-1/PD-L1 cellular pathway
Ninlaro (ixazomib)

FDA Approves Ninlaro for Multiple Myeloma

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New oral medication blocks certain enzymes, hindering cancer-cell growth
Narcan (naloxone hydrochloride) nasal spray has been approved by the U.S. Food and Drug Administration to stop or reverse an overdose of opioids.

FDA Approves Narcan Nasal Spray to Counter Opioid Overdose

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First-of-its-kind drug sanctioned to reverse effects of heroin or oxycodone use
Cotellic (cobimetinib) in combination with another chemotherapy

FDA Approves Cotellic for Advanced Melanoma

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For patients whose tumors express BRAF V600E or V600K mutations