January 01, 2012
Creation of the breakthrough therapy designation under FDASIA.
| Name | Type | Mentions | |
|---|---|---|---|
| FDA | person | 0 | View Entity |
HOUSE_OVERSIGHT_024018.jpg
This document appears to be a page from a confidential investment prospectus for a fund named 'NLV-III' (likely New Leaf Ventures). It outlines the investment strategy, focusing on biopharmaceutical trends such as FDA 'breakthrough therapy' designations and 'information convergence' in healthcare to reduce costs. The document cites a 2013 editorial by FDA Director Janet Woodcock and notes the evolving commercial models of large pharmaceutical companies.
Events with shared participants
FDA convened a meeting to analyze data on the drug Praluent, leading to its approval for a larger group of patients than expected.
Date unknown • U.S.
The FDA clearing the drug Praluent for patients with heterozygous familial hypercholesterolemia and certain types of heart disease.
Date unknown
FDA approval of Marinol and Cesamet
1985-01-01 • USA
Marinol approved for treatment of anorexia associated with AIDS
1992-01-01 • USA
Syndros approved by the FDA
2016-01-01 • USA
FDA gave green light for Geron clinical trial.
2009-01-01 • US
FDA accepted GW Pharmaceuticals’ New Drug Application (NDA) for the cannabis-derived drug Epidiolex.
2017-10-01 • USA
FDA published industry guidance on botanical drug development.
2016-12-01 • USA
Previous FDA guidance on botanical drugs issued.
2004-06-01 • USA
FDA convened meeting to analyze drug data.
Date unknown
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