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Sep 23, 2026Weekly roundup

FDA approves label update for TEPEZZA; Amgen registers MariTide bioavailability study

FDA approved a labeling supplement for TEPEZZA, and Amgen registered a Phase 1 trial comparing two MariTide drug product formulations.

This week's items cover an FDA label action and a newly registered Amgen trial.

  • The FDA approved supplement 33 for TEPEZZA (teprotumumab-trbw), a labeling submission for Horizon Therapeutics Ireland1, with an approval letter dated September 25, 2026 and an updated label dated September 28, 2026.
  • Amgen registered a Phase 1 trial titled "A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity" (NCT07832799)2, listed as not yet recruiting, with an estimated start date of 2026-10-122. The study will evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity2, with estimated enrollment of 340 participants2.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.