9 recent drug, device approvals

Nine drugs and medical devices approved by the FDA since August: 

  1. FDA approves first drug to treat rare metabolic disease
    The FDA approved Alnylam Pharmaceuticals' Oxlumo Nov. 23 to treat primary hyperoxaluria type 1, a rare genetic disorder.

  2. FDA expands approval of flu drug
    The FDA expanded its approval of Genentech's Xofluza Nov. 23 to include post-exposure prevention of influenza for patients 12 and older.

  3. FDA approves cardiovascular disease drug
    The FDA has approved Eiger BioPharmaceuticals' Zokinvy Nov. 20 to treat Hutchinson-Gilford progeria syndrome.

  4. Remdesivir becomes first FDA-approved COVID-19 treatment
    The FDA on Oct. 22 approved remdesivir, which Gilead Sciences sells under the brand name Veklury, as a COVID-19 treatment for hospitalized patients 12 and older.

  5. FDA grants first-ever Ebola drug approval to Regeneron
    The FDA on Oct. 14 approved Regeneron's Inmazeb, the first Ebola treatment to receive approval by the agency.

  6. FDA approves combination drug for mesothelioma
    The FDA approved Bristol-Myers Squibb's Opdivo in combination with Yervoy to treat mesothelioma Oct. 2.

  7. FDA approves drug for group of rare blood disorders
    The FDA approved GlaxoSmithKline's Nucala Sept. 25 to treat hypereosinophilic syndrome, a group of rare blood disorders.

  8. FDA approves new kind of insulin delivery device
    The FDA on Aug. 31 approved Medtronic's MiniMed 770G system, a diabetes device that automatically monitors glucose and provides insulin doses with little or no input from users.

  9. Novartis drug earns FDA approval to treat MS
    The FDA approvedNovartis' Kesimpta Aug. 20 to treat patients who have relapsing forms of multiple sclerosis.

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