FDA Approvals Calendar
Found 25 Results
Explore Enrichment Factors
November 2, 2020 12:00AM - November 2, 2020 12:00AM
Background. Recently we completed a project and explored the enrichment factors that can be used to increase the ability of the clinical trial to demonstrate the treatment effect. The analyzed ...
Nintedanib Receives Support to Treat Additional Lung Condition Associated with Rare Systemic Sclerosis
July 25, 2019 12:00AM - July 25, 2019 12:00AM
Committee: Arthritis Advisory Committee
Indications: The treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Question 1: Overall, do the data provide substantial ...
Pretomanid Passes FDA Ad Com as New Tuberculosis Treatment
June 6, 2019 12:00AM - June 6, 2019 12:00AM
Committee: Antimicrobial Drugs Advisory Committee
Indications: Pretomanid is a nitroimidazooxazine antimycobacterial drug indicated, as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary ...