Healthcare providers received significant updates this week, with the US Food and Drug Administration (FDA) advancing multiple key treatments. These developments include a new application for insulin human (Afrezza) Inhalation Powder in children and adolescents with diabetes, an updated indication for upadacitinib (Rinvoq) for ulcerative colitis and Crohn’s disease, and the clearance of a blood test for Alzheimer-related amyloid pathology.
FDA Approves New Applications and Updates
On October 13, 2025, the FDA accepted a supplemental biologics license application (sBLA) from MannKind Corporation. This application seeks approval for the use of insulin human (Afrezza) Inhalation Powder in children and adolescents diagnosed with type 1 or type 2 diabetes. The decision follows the results from the phase 3, 26-week, open-label INHALE-1 study, which demonstrated the medication’s efficacy. With the acceptance, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.
In the same week, the FDA approved a supplemental new drug application (sNDA) for AbbVie’s upadacitinib (Rinvoq). This update broadens the treatment indications for adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The new statement permits the use of upadacitinib after patients have received at least one approved systemic therapy when tumor necrosis factor blockers are not clinically advisable. Previously, the drug was limited to adults who had an inadequate response or intolerance to these blockers.
Innovations in Alzheimer’s Diagnostics and Treatment
The FDA also cleared the Elecsys pTau181 test, marking a significant advancement as the first blood test designed to rule out Alzheimer-related amyloid pathology. This test is intended for patients aged 55 years and older who present symptoms of Alzheimer’s disease. It aims to facilitate initial assessments for Alzheimer’s and other cognitive decline causes in primary care settings.
Additionally, recent data were presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam by Boehringer Ingelheim and Click Therapeutics. Their phase 3 trial revealed that an investigational prescription digital therapeutic, used alongside antipsychotic therapy, significantly reduced negative symptoms in patients with schizophrenia.
Finally, on October 16, 2025, Novartis announced promising final results from the phase 3 APPLAUSE-IgAN study of iptacopan (Fabhalta) in adults with IgA nephropathy (IgAN). This oral alternative complement pathway inhibitor demonstrated statistically significant superiority over placebo in slowing the progression of IgAN, as measured by the annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years. Novartis plans to leverage these findings to support regulatory submissions for iptacopan in 2026.
These advancements underscore the ongoing efforts to enhance treatment options and diagnostic capabilities in the healthcare sector, providing hope for better management of chronic conditions and improving patient outcomes.