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
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
January 7, 2021 – Kala Pharmaceuticals has announced the launch of EysuvisTM (loteprednol etabonate
ophthalmic suspension), which received U.S. FDA approval on October 26, 2020
January 6, 2021 – The U.S. FDA approved 50 novel drugs in 2021, down from 53 in 2020. Over the last five years, the agency has approved an average of 51 novel drugs per year.