January 22, 2021
January 22, 2021 –The U.S. FDA has approved LupkynisTM (voclosporin), manufactured by Aurinia
Pharmaceuticals, for use in combination with a background immunosuppressive therapy
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January 21, 2021
January 21, 2021 – The U.S. FDA has approved Cabenuva® (cabotegravir/rilpivirine), an extended-release,
injectable, complete regimen for the treatment of HIV-1 infection in adults.
January 19, 2021
January 19, 2021 – The U.S. FDA has approved a new indication for Enhertu® (fam-trastuzumab
deruxtecan-nxki), manufactured by Daiichi Sankyo. Enhertu is now indicated to treat
January 19, 2021
January 19, 2021 – The U.S. FDA has approved Verquvo® (vericiguat), manufactured by Merck, to reduce
the risk of cardiovascular (CV) death and hospitalization for heart failure in adults who have
January 15, 2021
January 15, 2021 – The U.S. FDA has approved a new indication for Darzalex Faspro® (daratumumab/
hyaluronidase-fihj), manufactured by Janssen Biotech. The drug is now indicated for use
January 14, 2021
January 14, 2021 – The U.S. FDA has approved a new indication for Xalkori® (crizotinib), manufactured by
Pfizer. The drug is now indicated to treat relapsed or refractory, systemic anaplastic large
January 8, 2021
January 8, 2021 – The U.S. FDA has approved 53 new drugs in 2020, nearing its record of 59 new approvals
in one year, which was set in 2018.
Fifty-three new drug approvals would be a significant number under any circumstances
January 8, 2021
January 8, 2021 – Fresenius Kabi has voluntarily recalled one lot of Ketorolac Tromethamine Injection,
USP, 30mg/mL, 1mL fill in a 2mL amber vial. The recall is due to the presence of particulate