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News

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29 items

FRI 30 OCT 2026

WED 28 OCT 2026

TUE 27 OCT 2026

WED 21 OCT 2026

WED 23 SEP 2026

Regulatory
PHN-0316
2026-09-23 14:50 CT
Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions

FDA press releases

According to the FDA, a federal court entered a consent decree against Gold Star Distribution, Inc. following persistent insanitary warehouse conditions. The Sept. 21, 2026 order stops distribution of FDA-regulated products until the company brings its operations into compliance with federal requirements.

MON 21 SEP 2026

WED 16 SEP 2026

Trial
PHN-0263
2026-09-16 19:00 CT
Clinical Trial in Patients With Barth Syndrome- 4TAZPower

ClinicalTrials.gov: elamipretide

ClinicalTrials.gov lists 4TAZPower as recruiting for a 72-week, Phase 3b/4 placebo-controlled trial of elamipretide in patients with genetically confirmed Barth syndrome. The listing says the trial aims to confirm efficacy following U.S. accelerated approval of FORZINITY based on improved knee extensor muscle strength.

Trial
PHN-0264
2026-09-16 19:00 CT
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)

ClinicalTrials.gov: elamipretide

The ClinicalTrials.gov listing describes ReNEW as an active Phase 3 trial of elamipretide for dry age-related macular degeneration that is no longer recruiting. The study compares elamipretide with placebo to evaluate efficacy, safety and pharmacokinetics.

MON 11 MAY 2026

WED 29 APR 2026

Trial
PHN-0259
2026-04-29 19:00 CT
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)

ClinicalTrials.gov: survodutide

ClinicalTrials.gov lists SYNCHRONIZE-MASLD as completed, a study testing survodutide against placebo for reducing liver fat and body weight in adults with overweight or obesity and presumed or confirmed NASH. Participants were assigned randomly to two groups; the provided excerpt contains no results.

Clinical trialOriginal source ↗

THU 12 MAR 2026

THU 11 DEC 2025

THU 23 OCT 2025

Trial
PHN-0267
2025-10-23 19:00 CT
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

ClinicalTrials.gov: elamipretide

ClinicalTrials.gov lists SPIMD-301, a 48-week trial evaluating elamipretide in people with primary mitochondrial myopathy associated with nuclear DNA mutations, as completed. The randomized, double-blind, placebo-controlled study assessed efficacy and safety; the excerpt provides no results.

THU 11 JUL 2024

Trial
PHN-0268
2024-07-11 19:00 CT
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA

ClinicalTrials.gov: elamipretide

ClinicalTrials.gov lists the ReCLAIM-2 study of elamipretide as completed. The randomized, double-masked, placebo-controlled trial evaluated safety, efficacy and pharmacokinetics in people with age-related macular degeneration and non-central geographic atrophy; the excerpt provides no results.

MON 15 APR 2024