Diana Ernst

BioCryst announces US FDA approval of Orladeyo ® 150mg oral pellets for adults and adolescents with HAE. News release. BioCryst. October 21, 2026.

Ultomiris received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy.

The Food and Drug Administration (FDA) has approved Vykat™ XR (diazoxide choline) for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

Topline results were announced from the phase 3 FURVENT trial evaluating firmonertinib, an investigational epidermal growth factor receptor (EGFR) tyrosine

| Publish Date The Food and Drug Administration (FDA) has approved Monjuvi ® (tafasitamab-cxix), in combination with lenalidomide

US Food and Drug Administration. FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication. October 22, 2026.

US FDA approves subcutaneous induction regimen for AbbVie's Skyrizi® (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease.

The Food and Drug Administration ( FDA ) has expanded the approval of Awiqli ® (insulin icodec-abae) to include pediatric patients aged 10 years and older with type 2 diabetes (T2D).

Pfizer's Talzenna plus Xtandi FDA-approved for an earlier metastatic prostate cancer treatment setting. News release. Pfizer. October 26, 2026.

| Publish Date The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for