FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Oral semaglutide demonstrated significant improvements in multiple cardiometabolic risk factors in adults with type 2 diabetes at high cardiovascular risk. The SOUL trial analysis showed reductions in systolic blood pressure, cholesterol, triglycerides, HbA1c, and body weight compared to placebo. These benefits were observed as early as 13 weeks and contributed to a 14% reduction in major adverse cardiovascular events.
Eli Lilly's orforglipron demonstrated superior A1C reduction and weight loss compared to oral semaglutide in the ACHIEVE-3 trial, with regulatory submissions filed in over 40 countries and a potential US decision expected in Q2 2026.
Orforglipron, an oral GLP-1 receptor agonist, demonstrated greater reductions in HbA1c and body weight compared to oral semaglutide in adults with type 2 diabetes, with more patients achieving strict glycemic targets at one year.
