27 results

• Tavneos Liver Injury Risks, Faked Data Lead FDA To Seek Market Removal

  April 29, 2026

  Irvin Jackson

  Amgen has received a letter from the FDA indicating the agency plans to remove Tavneos from the market after discovering falsified data in the original clinical trial.

• Tavneos Side Effects Linked to Severe Liver Injuries, FDA Warns

  April 1, 2026

  Michael Adams

  Federal regulators warn Tavneos may cause serious and potentially fatal liver injuries, with postmarketing data identifying 76 adverse cases, including 54 hospitalizations and eight deaths.

• Hundreds of Imdelltra Side Effects Went Unreported to FDA Before Cancer Drug’s Approval: Report

  August 16, 2024

  Irvin Jackson

  A new report indicates Amgen failed to report 400 adverse events that occurred during clinical trials for the recently-approved cancer drug Imdelltra, linked to increased risks of cytokine release syndrome and neurotoxicity.

• FDA Warns Prolia May Cause Severe Low Blood Calcium Levels

  January 22, 2024

  Irvin Jackson

  The FDA has added a black box label warning that indicates Prolia side effects can cause severely low blood calcium levels which could lead to hospitalization or death.

• FTC to Allow Tepezza Manufacturer to be Bought By Amgen Amid Growing Hearing Loss Litigation

  September 12, 2023

  Irvin Jackson

  The FTC has agreed to allow Amgen to buy Horizon, the manufacturer of Tepezza, after proposing a consent decree which seeks to prevent the company from gaining an overwhelming advantage on its competitors.

• FTC Files Lawsuit To Prevent Amgen From Acquiring Manufacturer of Tepezza, Krystexxa

  May 19, 2023

  Irvin Jackson

  The FTC has filed a complaint to stop Amgen from acquiring Horizon Therapeutics, saying it would give the manufacturer a monopoly on certain drugs, like Tepezza.

• Investors File Lawsuit To Prevent Acquisition of Tepezza Manufacturer Horizon Therapeutics

  January 9, 2023

  Irvin Jackson

  Two investors have filed lawsuits to stop the acquisition of Tepezza manufacturer Horizon Therapeutics, claiming the company is hiding material financial projections from shareholders who must approve the deal.

• Horizon Therapeutics Acquired for Nearly $30B Amid Growing Threat of Tepezza Lawsuit Payouts

  December 15, 2022

  Irvin Jackson

  Despite the threat of having to eventually pay Tepezza lawsuit payouts, Amgen has acquired the drug's manufacturer, Horizon Pharmaceuticals for nearly $30 billion.

• Prolia Hypocalcemia Problems Among Dialysis Patients Results in FDA Investigation

  November 23, 2022

  Russell Maas

  The FDA warns Prolia has been linked to dangerously low calcium blood levels.

• Woman Suffers Multiple Vertebral Fractures After Stopping Prolia: Case Report

  May 16, 2022

  Irvin Jackson

  A new case report warns that Prolia discontinuation can lead to vertebral fractures in bone cancer patients.