Over the past decade, the percentage of novel drug approvals for rare diseases (diseases that affect fewer than 200,000 people in the US) has increased (FDA - Rare Disease Day 2023, Pharmaceutical Technology). The question will be suspended on 31 December 2024 and the outcome determined using data as reported by the FDA for novel drug approvals in 2024 (FDA - New Drugs). In 2022, the FDA approved 20 novel drugs for rare diseases (FDA - New Drug Therapy Approvals 2022).

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