December 1, 2020 – The U.S. FDA has approved a new indication for Xolair® (omalizumab), manufactured by Genentech. The drug is now indicated for use as an add-on maintenance treatment
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 27, 2020 – The U.S. FDA has approved ImcivreeTM (setmelanotide), manufactured by Rhythm Pharmaceuticals, to provide for chronic weight management for patients who are at least
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 – 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 – 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 – 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 –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