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5 FDA decisions to watch in the fourth quarter

October 3, 2022


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.

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