December 4, 2020
December 4, 2020 –The U.S. FDA has approved a label update for Merck’s Januvia® (sitagliptin), Janumet®
(sitagliptin/metformin hydrochloride), and Janumet® XR (sitagliptin/metformin
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December 1, 2020
December 1, 2020 – The U.S. FDA has approved a new indication for Hetlioz® (tasimelteon), manufactured by Vanda Pharmaceuticals. Originally FDA approved in 2014 to treat non-24-hour
November 25, 2020
November 25, 2020 – The U.S. FDA has approved Danyelza® (naxitamab-gqgk), manufactured by Y-
mAbs Therapeutics, for use in combination with granulocyte-macrophage
November 23, 2020
November 23, 2020 – The U.S. FDA has approved OxlumoTM (lumasiran), manufactured by Alnylam
Pharmaceuticals, to treat primary hyperoxaluria type 1 (PH1), lowering urinary oxalate levels
October 22, 2020
October 22, 2020 – The U.S. FDA has approved Veklury® (remdesivir), manufactured by Gilead, to treat
COVID-19 in patients who require hospitalization, are at least 12 years of age
October 22, 2020
October 22, 2020 – October 22, 2020 – Breaking a four-year pattern of approving record numbers of generic drugs, the U.S.
FDA issued 909 generic drug approvals in fiscal year (FY) 2020 compared
October 15, 2020
October 15, 2020 –The U.S. FDA has approved an expanded indication for Keytruda® (pembrolizumab),
manufactured by Merck. The drug is now indicated for use as a monotherapy
October 14, 2020
October 14, 2020 – The U.S. FDA has approved Inmazeb® (atoltivimab/maftivimab/odesivimab-ebgn), a novel anti-viral antibody medicine manufactured by Regeneron, to treat