An Overview of FDA-approved Anticancer and Biologics in 2023: AnObservational Study

Background: The United States Food and Drug Administration (US FDA) is responsible for ensuring public health by conducting a comprehensive assessment and approval of pharmaceuticals, medical devices, and food products. The federal agency conducts a thorough evaluation of drug safety and efficacy before granting market approval. Material and Methods: This retrospective study aimed to analyse all new drug approvals that took place during the 2023 study period using an observational, record-based approach. To gather data on drug approvals by the US FDA, we relied on the FDA database website. We also conducted a literature search on electronic databases like PubMed, clinicaltrials.gov, and the Cochrane database to gather comprehensive drug-related information Results: In the CY 2023, a total of 55 drugs were approved by US-FDA. Out of which 23 drugs (42%) were given orphan drug designation and 12 drugs (22%) were approved in first in class category during this period. US-FDA has gave 7 breakthrough approvals, 22 priority, 18 fast track, 2 Qualified Infectious Disease Product Designation, 4 accelerated approvals in CY2023. There were 16 drugs (29%) which were approved for cancer in 2023 by US-FDA. Out of 16 drugs, 06 belongs to tyrosine kinase class, 07 were monoclonal antibody and 01 each of gamma secretase inhibitor, estrogen receptor antagonist and radioactive drug. During the CY 2023, 16 (29%) biological drugs were approved which included monoclonal antibodies, (N=12), enzymes derivatives (N= 3) and hormones derivatives (N=1) Conclusion: Notable advancements in the drug development market were witnessed between 2015 and 2022, and 2023 was no different. The total number novel drugs approved was significantly higher than previous year. Expedited approval of anticancer and biologics is seen as recent trend in drug development.