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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

DateArticle
Jan 10, 2024Open Enrollment Commences for Phase 1b/2 Study Evaluating Ampligen in Combination with Imfinzi for the Treatment of Pancreatic Cancer
Oct 12, 2022AIM ImmunoTech to Evaluate Ampligen in Clinical Study for the Treatment of Post-COVID Conditions
Feb  9, 2015Hemispherx Biopharma Posts USAMRIID Ebola Study Concluding Ampligen Produced 100% Survival Rate in Rodents with 100% Mortality in Placebo
Dec  9, 2014Hemispherx Announces Data Showing Inhibition of Ebola by Ampligen Enlarged by Howard University Research
Feb  5, 2013Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen New Drug Application for Chronic Fatigue Syndrome
Dec 27, 2012FDA Advisory Committee Makes Recommendations on Ampligen for Chronic Fatigue Syndrome
Oct 23, 2012Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
Sep 24, 2012Hemispherx Biopharma Announces FDA Advisory Committee Will Review Ampligen for Chronic Fatigue Syndrome
Aug 14, 2012FDA Accepts Complete Response Submission Regarding the Ampligen New Drug Application for Chronic Fatigue Syndrome
Aug  1, 2012Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome
Mar  7, 2008Hemispherx Biopharma Reaches Agreement With FDA on Specific Steps to Achieve Complete NDA on Proposed CFS Treatment Ampligen
Jan  9, 2008Hemispherx Biopharma Addresses FDA Questions On Ampligen NDA
Oct 11, 2007Hemispherx Biopharma Files New Drug Application for Ampligen as Treatment for Chronic Fatigue Syndrome

Further information

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