February 16, 2021 - A new-to-market drug is precisely what it sounds like – a drug that has recently been approved and
released for sale in the United States market.
January 22, 2021 –The U.S. FDA has approved LupkynisTM (voclosporin), manufactured by Aurinia
Pharmaceuticals, for use in combination with a background immunosuppressive therapy
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 – 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 – 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 – 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 – 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 – 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