January 01, 2018
NDA submission leading to FDA approval
| Name | Type | Mentions | |
|---|---|---|---|
| FDA | person | 0 | View Entity |
| Richard Langworth | person | 4 | View Entity |
HOUSE_OVERSIGHT_024903.jpg
This document is page 87 of a 'Cowen Collaborative Insights' report dated February 25, 2019, analyzing the pharmaceutical market for cannabinoid-based drugs, specifically focusing on GW Pharmaceuticals' Epidiolex and its clinical trials for epilepsy. The text details statistical results from Phase III trials, FDA approval timelines, and efficacy comparisons against placebos. The document bears a 'HOUSE_OVERSIGHT_024903' stamp, indicating it was part of a document production for a congressional investigation, and is watermarked for Michael Cella at Cowen.
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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