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5 FDA decisions to watch in the first quarter

January 4, 2024


Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines.

By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while the agency’s biologics division cleared 15 more. The clearances offer some counterbalance to a prolonged market downturn, during which the sector has struggled with a range of financial and regulatory headwinds.

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