Through June 30, 2024, the FDA approved 27 novel pharmaceutical products for use in the United States. While 2023 was a record-breaking year with 72 novel approvals, this year is expected to approach that number. Of the novel approval’s year-to-date, 18 are specialty drugs. 13 have an Orphan Drug Designation and 11 are Breakthrough Therapies. In the second half of 2024, the FDA could approve an additional 37 novel drugs, which would bring the total novel approvals for the year to 65. Of the 37, 27 would be considered specialty while 10 are classified as traditional drugs. Although various drug classes are represented, the pipeline includes several new oncology treatments as well as medications to treat Alzheimer’s Disease.
