December 3, 2020
December 3, 2020 – The U.S. FDA has approved OrladeyoTM (berotralstat), manufactured by BioCryst Pharmaceuticals, to provide prophylaxis (prevention) of hereditary angioedema (HAE)
December 1, 2020
December 1, 2020
December 1, 2020 – The U.S. FDA has approved two new indications for GavretoTM (pralsetinib),
manufactured by Roche and Blueprint Medicines, to treat certain types of thyroid cancer.
December 1, 2020
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
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
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
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