FDA Launches Major CGMP Review

Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.

Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).

Real-world data show weight loss after switching to the Wegovy pill, Lilly reports positive hand and foot atopic dermatitis data, and Teva wins FDA approval for a Xgeva biosimilar.

In the OCTANE real-world analysis presented at EASD 2026, adults who switched from injectable semaglutide or tirzepatide to once-daily oral semaglutide lost an average of 4.1% of body weight after 3 months.

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

More than half of patients achieved clear or almost clear hands and feet with lebrikizumab by week 16, and 77% reported satisfaction with clearance.