The FDA is conducting a two-day review of a controversial proposal to permit compounding pharmacies to manufacture seven peptides. The decision has drawn attention from career FDA scientists, newly appointed panelists with financial ties to peptide prescribing, and Department of Health and Human Services leadership that favors expanded access to these substances. While regulating compounded peptides could discourage patients from using unregulated products, critics worry that broadening availability without stronger clinical data could confer unwarranted legitimacy to therapies with poorly understood safety profiles. An academic researcher noted that the central public health question centers on whether these products should reach wider availability before sufficient evidence of their benefits and risks is established.
In other pharmaceutical developments, Revolution Medicines has submitted a new drug application for daraxonrasib following Phase 3 study results showing the pancreatic cancer therapy improved overall survival and progression-free survival compared to standard chemotherapy. The FDA is reviewing the application through an expedited pathway that may accelerate the approval timeline.
GlaxoSmithKline received FDA approval for Jideytro, marking the company’s first lung cancer drug following its recent acquisition of Nuvalent. The approval covers advanced or metastatic lung cancer patients with ROS1 mutations who have previously tried another ROS1 kinase inhibitor. The approval arrived substantially ahead of the FDA’s target review date.
Arrowhead Pharmaceuticals disclosed Phase 3 data for plozasiran showing the treatment reduced pancreatitis rates by 78 percent versus placebo and decreased triglyceride levels by approximately 80 percent after one year. The company plans to seek FDA approval by year-end, positioning the drug to compete directly with Ionis’s recently approved Tryngolza for severe hypertriglyceridemia treatment.
Elaborating on obesity drug research, Eli Lilly reported that retatrutide produced expected weight loss results in Phase 3 testing. However, the study did not demonstrate statistically significant cardiovascular benefits, though patients receiving the highest dose showed improvements in certain cardiovascular risk factors.
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