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
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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
October 14, 2020
October 14, 2020 – The U.S. FDA has approved an expanded indication for Wakix® (pitolisant),
manufactured by Harmony Biosciences. The drug is now indicated to treat
October 13, 2020
October 13, 2020 – The U.S. FDA has issued a safety communication in regard to proper dispensing of insulin pens. These products should typically be dispensed in their original
October 5, 2020
October 5, 2020 – The U.S. FDA’s Center for Drug Evaluation and Research (CDER) has proposed that
Makena® (hydroxyprogesterone caproate injection – AMAG Pharmaceuticals)
October 2, 2020
October 2, 2020 – Marksans Pharmaceuticals has voluntarily expanded its June 5, 2020, recall of Metformin Hydrochloride Extended-Release (ER) Tablets, USP 500mg and 750mg