FDA rejects rintatolimod (AmpligenT) for chronic fatigue syndrome
Source: BioSpace
Area: News
The US Food and Drug Administration has rejected the New Drug Application for rintatolimod (AmpligenT), an injectable immunomodulator being investigated for chronic fatigue syndrome (CFS).
The Agency considered that the evidence provided by the company did not provide sufficient information to determine whether the product is safe and effective for CFS.
It will require the company to conduct at least one addition clinical trial of the medicine, complete various nonclinical studies and perform further data analysis.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news