Nearly 1 In 3 Recent FDA Drug Approvals Followed by Major Safety ActionsSydney LupkinKaiser Health News
Recent drug approvals for newly diagnosed acute myeloid leukemia: gifts or a Trojan horse?Since 2017 the US Food and Drug Administration (FDA) has approved glasdegib, venetoclax, ivosidenib, midostaurin, CPX- 351, and gemtuzumab ozogamicin (GO) to treat persons with newly diagnosed acute myeloid...
Recent FDA-Approvals: KRAS G12C-Mutated NSCLC EP: 10.NSCLC: Sotorasib in Practice EP: 11.Recent FDA-Approvals: HER2-Mutated NSCLC EP: 12.Recent FDA-Approvals: MET Exon 14 Mutations in NSCLC EP: 13.RET-Fusions in NSCLC: Updates From ASCO EP: 14.ALK-Rearranged NSCLC: Updates From ...
The last 2 years have been a very active period for the clinical testing and FDA approval of diverse molecularly targeted treatments in AML, with several new agents and additional clinical trials currently underway. As a result of these drug developments, more options are now available for patient...
Recent FDA Approvals Psychiatric TimesGoodstein, Richard K.
Kelly Goodwin, MSN, RN, ANP-BC, discusses the significance of the recent FDA approvals of capmatinib and trastuzumab deruxtecan for patients with non–small cell lung cancer. Kelly Goodwin, MSN, RN, ANP-BC Last month, 2 targeted therapies were added to the fold of FDA approved non–...
Recent US FDA approvalsInpharma Weekly -doi:10.2165/00128413-200112870-00060NoneSpringer International PublishingInpharma Weekly
FDA decisions (approvals/complete response letter/delay) According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc. FDA’s Advisory Committee, or Adcom, meetings Review meetings with FDA (pre-investigational ...
FDA: U.S. Food and Drug Administration FXII: Coagulation factor XII FXIIa: Activated coagulation factor XII HAE: Hereditary angioedema HK: High molecular weight kininogen HUK: Human urinary kallidinogenase IVIG: Intravenous immunoglobulin Ir-CPI: ...
In addition, a glimpse of the pipeline reveals a number of prodrugs undergoing clinical trials, many of them likely crossing the approval threshold in the near future. We hope that this review have raised interest and awareness of the potential of using prodrugs in drug discovery and development...