fda warning letters compounded semaglutide telehealth 2025 warns providers over obesity drug marketing From Crackdown to Collaboration: FDA

While their metabolic benefits are established, concerns persist about a possible link with gastrointestinal (GI) cancers

Medullary thyroid cancer and C-cell hyperplasia remain a boxed warning for both medications based on animal studies, not human evidence

[11] It is not known whether sermorelin can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity

For firms litigating GLP-1 claims, the ruling may affect case valuation, injury screening, discovery strategy, expert planning, and the range of claims that survive into later phases of the MDL

They provide the primary analyzable clinical data for metabolic efficacy, specifically focusing on absolute and percentage changes in body weight and reductions in HbA1c (Table 3)