Five years after filing for an approval of the chronic fatigue syndrome drug Ampligen, the FDA has spurned the application again, asking for additional information and another clinical trial.
Hemispherx Biopharma's RNA-based adjuvant, Ampligen (rintatolimod), is being tested in a new indication--this time intranasally for the first time in humans along with AstraZeneca's nasal flu vaccine FluMist.
Hoping to overcome the FDA's concerns regarding Ampligen, Hemispherx announced that it has submitted new preclinical data for the drug to regulators. The agency had rejected Ampligen after concluding
Hemispherx BioPharma was dealt a heavy blow yesterday, watching its already battered share price plunge 44 percent after the developer announced that the FDA demanded to see more information from a
Hemispherx had investors excited this week with the news of an analyst call on the company's flu initiatives, but the upward trend didn't last long. After skyrocketing more than 55 percent...
Hemispherx Biopharma says the FDA, citing an increased workload, has extended its review for Ampligen for the treatment of chronic fatigue syndrome. No drug candidate has received FDA approval for