BioPharma Dive October 3, 2022
The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.
Though 2022 has been a down year for the biotechnology sector, notable decisions from the Food and Drug Administration have provided a few bright spots.
Two gene therapies came to market, providing a lift for a field that’s been slowed by recent setbacks. The cancer drug Enhertu was approved for a newly defined tumor type known as “HER2-low.” The regulator also cleared a new medicine for ALS and a first-of-its-kind inflammatory disease drug.
The fourth quarter could yield some other medical milestones. An Alzheimer’s drug that unexpectedly succeeded in a large trial last...