Several orphan drugs received FDA approval in the first quarter of 2024, marking significant advancements in treatments for rare diseases. These approvals are crucial for patients suffering from conditions that often lack dedicated therapeutic options.
The newly approved orphan drugs as of early 2024 include:
Newly Approved Orphan Drugs (Q1 2024)
| Orphan Drug | Approval Date (PDUFA Date) | Status |
|---|---|---|
| Brukinsa (zanubrutinib) | First Quarter 2024 | APPROVED |
| Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] | January 16, 2024 | APPROVED |
| Dupixent (dupilumab) | January 31, 2024 | APPROVED |
These approvals highlight the ongoing efforts to address unmet medical needs within the rare disease community, providing new hope and treatment possibilities.
