fda warning letters glp-1 october 2025 CDER Jump 50% in FY — What That Means for Industry FDA AI Warning Letter (Purolea):

Neuroinflammation and the immune system Microglia mediate the immunomodulatory processes in the brain and play a crucial role in the neuroinflammation in PD, leading to chronic activation and releasing of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-) and interleukin-1 beta (IL-1), which further increase the damage in neurons and promote disease progression 41

To one medium, 16 L of Sodium Hydrogen L (+)-Glutamate monohydrate (Wako) dissolved in sterile water was added at final concentrations of 1, 5, 20, and 40 mM, and to the other medium, only 16 L of sterile water was added

Sarcopenia Approximately 40% of the weight reduction associated with GLP-1 RAs is derived from a lean body mass, which raises significant concerns regarding its potential negative impact on skeletal muscle functionality [110]

1 Tirzepatide activity in mice

Although current studies on trained immunity in sarcoidosis are limited, its pathological features and underlying principles suggest opportunities for early intervention against adverse progression

In contrast, GSH depletion drives M1 polarization, resulting in heightened secretion of pro-inflammatory cytokines, including TNF-, IL-6, and IL-1 (Kwon et al., 2019)