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Phase3.bio places the FDA review team’s deliberative process for drug evaluation into perspective so directors of research at drug development companies better understand the implications for their pending drug approvals. Learn More
FDA Approvals Calendar
FDA Approvals Calendar
Found 25 Results
Explore Enrichment Factors
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
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
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 ...