The wider US HHS is going through a leadership upheaval, as Republicans aim to keep voters on side amid the looming midterm elections.
OTXL’s COO, Beth White, notes that the CGTxchange platform could revitalise CGT programmes that would otherwise have been indefinitely put on ice.
The analysis compared outcomes from the Phase III OASIS-4 trial and ATTAIN-1 in adults with overweight or obesity without diabetes.
The approval covers the use of Enhertu in both the neoadjuvant and adjuvant treatment settings for adult patients.
GLP-1 agonists have had a dramatic surge in popularity in recent years as a treatment for obesity and type 2 diabetes (T2D).
The approval is based on Phase III FIBRONEER-IPF and FIBRONEER-ILD clinical trials conducted in parallel.