Each year, regulatory bodies across the world provide marketing approvals for various novel chemical and biological entities. In addition, extended approvals are provided for old entities for new indications based on new trial data that emerge every year (an aspect also called “drug repurposing”). United States Food and Drug Administration (US-FDA) is one of the prime regulatory bodies in the world, and approvals granted by US-FDA are then replicated across other countries’ regulatory agencies, with or without additional local data. This chapter lists the significant regulatory approvals granted by the US-FDA in the past 5 years, along with the approved indications and key clinical guidance. This list, however, is not extensive, and does not indicate that these entities are approved across all geographies.