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5 FDA decisions to watch in the first quarter

January 4, 2024

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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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