Ampligen FDA Approval Status
FDA Approved: No
Brand name: Ampligen
Generic name: rintatolimod
Company: Hemispherx Biopharma, Inc.
Treatment for: Chronic Fatigue Syndrome
Ampligen (rintatolimod) is an experimental nucleic acid therapeutic in development for the treatment of a variety of chronic diseases and viral disorders.
Development timeline for Ampligen
| Date | Article |
|---|
| Oct 12, 2022 | AIM ImmunoTech to Evaluate Ampligen in Clinical Study for the Treatment of Post-COVID Conditions |
| Feb 9, 2015 | Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo |
| Dec 9, 2014 | Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research |
| Feb 5, 2013 | Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome |
| Dec 27, 2012 | FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome |
| Oct 23, 2012 | Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012 |
| Sep 24, 2012 | Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome |
| Aug 14, 2012 | FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome |
| Aug 1, 2012 | Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome |
| Mar 7, 2008 | Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps
to Achieve Complete NDA on Proposed CFS Treatment Ampligen |
| Jan 9, 2008 | Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA |
| Oct 11, 2007 | Hemispherx Biopharma Files New Drug Application for Ampligen as
Treatment for Chronic Fatigue Syndrome |
Further information
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