FDA again targets GLP-1 compounders; Intellia to restart heart disease trial
The FDA has issued 30 warning letters to telehealth companies for making false claims about compounded GLP-1 products, marking its second round of such actions. Separately, Intellia Therapeutics received clearance to resume a Phase 3 trial for a heart condition, having implemented new safeguards after a participant's death. Furthermore, United Therapeutics' pulmonary arterial hypertension drug, ralinepag, surpassed expectations in a Phase 3 trial, and Merck detailed positive study results for its kidney cancer drug, Welireg.
https://www.biopharmadive.com/news/fda-compounders-intellia-acip-ralinepag-merck-walireg/813555/