Review of FDA's New Drug Approval Report 2018-2020

1.1 Cancer 1.2 Infections A total of seven diagnostic reagents have been approved in 2019 and 2020, six of which are PET diagnostic reagents for the diagnosis of the nervous system and tumors.
1) fluorodopa F 18: Parkinson's Diagnostics 2) Ga 68 DOTATOC: Neuroendocrine Tumor Diagnostics 3) Cerianna (fluoroestradiol F 18): PET diagnostic reagents for ER-positive recurrence or metastatic breast cancer.
4) Detectnet (copper Cu-64 dotatate): PET diagnostic reagent for neuroendocrine tumors that are positive for growth inhibitor.
5) Gallium Ga 68 PSMA-11: PSMA-positive PET diagnostic reagent for prostate cancer.
6) Tauvid (flortaucipir F 18): Analysis of tau protein distribution or accumulation of PET diagnostic reagents in Alzheimer's patients.
In particular, in its 2020 report, the FDA reported more new adaptations than in the previous two years combined, including major breakthroughs in certain diseases: 1) Benlysta: the first FDA-approved drug to treat lupus nephritis.
2) Keytruda: A first-line treatment for non-surgical microsatellial instability or misalmissing to repair defective colorectal cancer, the first FDA-approved first-line immunotherapy that does not include chemotherapy.
to expand the use of approved drugs is to expand the use of populations, such as children.
Most innovative drugs do not include children when they are first introduced, and in 2003 the United States enacted the Pediatric Research Equity Act ,PREA, which requires pediatric research for all innovative drugs except in exceptional circumstances.
1) In 2019, the FDA approved lyxi monomatic granuloma with polyangiotis (GPA) and microscopic hyperarthritis (MPA) adaptations for use in children over 2 years of age.
2) In 2020, Epclusa's adaptation will include children over 6 years of age weighing more than 17 kg.
is the first hepatitis C drug approved to treat all six strains in children.