A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels o...
FDA. Advancing health through innovation: 2018 new drug therapy approvals https://www.fda.gov/media/120357/download (2019). Chen, E. Y., Joshi, S. K., Tran, A. & Prasad, V. Estimation of study time reduction using surrogate end points rather than overall survival in oncology clinical ...
new biological products, gene and cell therapies, new vaccines, and new traditional Chinese medicines approved for the first time in mainland China. Chemical drugs accounted for the largest proportion of new drug approvals (72, or 69.2
Dietary management of adults with IBD — the emerging role of dietary therapy Article 16 May 2022 Understanding the therapeutic toolkit for inflammatory bowel disease Article 31 January 2025 The effect of adding pancreatin to standard otilinium bromide and simethicone treatment in type 2 diabetes...
2022 drug approvals: After Aduhelm fiasco, FDA endorsements drop to 37 On the flip side, the FDArejectedEli Lilly’s touted Alzheimer’s treatment donanemab. But the company appears to be on track for approval in 2024. Other big winners in ’23 ...
Microbiomes.Vowst becamethe first microbiome-based drug to receive FDA approval in 2023 for the prevention of recurrence ofC. difficileinfection. Companies are also assessing the value of microbiomes for treating gastrointestinal, immunological, and oncological diseases. But the microbiome modality has ...
complicationsTrusted Source. But some people with type 2 diabetes cannot reach blood sugar goals with currently available combination therapies.The need for new, more effective treatment options forms the basis of the FDA’s approval of tirzepatide, a novel drug for type 2 diabetes.How does it ...
2022 Biological approvals. Accessed March 29, 2023. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2022-biological-approvals 34. Eder J, Sedrani R, Wiesmann C. The discovery of first-in-class drugs: origins and evolution. Nat Rev Drug Discov....
Summit Therapeutics expects to conduct at least 1 additional clinical trial of RDZ before achieving full market approval from the FDA.8 Cefepime-taniborbactam may represent a safe and effective carbapenem-sparing agent in cUTI and AP, whereas ridinilazole may play an important role in treating ...