BioPharma Dive October 3, 2022
Ben Fidler, Ned Pagliarulo, Delilah Alvarado, Jacob Bell and Jonathan Gardner

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...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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