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
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News
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
October 2, 2020
October 2, 2020 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab) used in
combination with Yervoy® (ipilimumab) to provide first-line treatment of adults