The HCPFive: Top News for Healthcare Providers from the Week of 09/20

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals. Each week, we highlight 5 key developments or headlines from healthcare that you need to know — whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine.

This week's top stories include the US Food and Drug Administration (FDA) Priority Review of Insmed's supplemental new drug application (sNDA) for amikacin liposome inhalation suspension (Arikayce) for Mycobacterium avium complex (MAC) lung disease, the approval of a sotatercept-csrk (Winrevair) label update to include efficacy and safety data from the phase 3 HYPERION trial in adults with pulmonary arterial hypertension (PAH) diagnosed within the previous 12 months, phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 data for barzolvolimab in antihistamine-refractory chronic spontaneous urticaria (CSU), and the FDA approvals of insulin efsitora alfa-gobe (Onswik) to improve glycemic control in adults with type 2 diabetes as well as obinutuzumab (Gazyva) for adult and pediatric patients ≥ 2 years of age with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here's your quick dive into the top stories for the week of September 20, 2026 — let's jump in!

FDA Grants Priority Review for Insmed's ARIKAYCE sNDA for MAC Lung Disease

On September 21, 2026, the FDA granted Priority Review to Insmed's supplemental new drug application (sNDA) for amikacin liposome inhalation suspension (ALIS; Arikayce) seeking full approval for newly diagnosed and recurrently infected MAC lung disease.

Amikacin liposome inhalation suspension is currently approved only under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for refractory MAC lung disease in patients who have failed ≥ 6 months of multidrug therapy without achieving negative sputum culture conversion. If approved, the sNDA would expand the label to frontline use as part of combination antibacterial therapy, moving amikacin liposome inhalation suspension from a refractory-disease option to a treatment-naive one.

FDA Updates Sotatercept Label with HYPERION Data in Early PAH

On September 22, 2026, the FDA approved a label update for sotatercept-csrk (Winrevair) to include efficacy and safety data from the phase 3 HYPERION trial in adults with PAH diagnosed within the previous 12 months.

The activin signaling inhibitor already carries approval for adults with PAH (WHO Group 1) to improve exercise capacity and WHO functional class and to reduce clinical worsening events, including hospitalization, lung transplantation, and death. The HYPERION update extends label evidence to patients earlier in their disease course, adding to prior data from the STELLAR and ZENITH trials.

EMBARQ-CSU: Barzolvolimab Meets Primary, Secondary Endpoints in CSU Trials

On September 22, 2026, Celldex Therapeutics reported topline results from the phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab (CDX-0159), showing the anti-KIT monoclonal antibody met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at week 12 in patients with antihistamine-refractory CSU. The studies represent the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU.

Weekly Insulin Efsitora Alfa (Onswik) Gains FDA approval for Type 2 Diabetes

On September 24, 2026, the FDA approved insulin efsitora alfa-gobe (Onswik), a once-weekly basal insulin, to improve glycemic control in adults with type 2 diabetes, based on 4 phase 3 QWINT trials. According to parent company Eli Lilly, efsitora is designed to maintain steady basal insulin levels across a full 7-day dosing interval, reducing basal injections from approximately 365 to 52 per year vs once-daily basal insulin. The US decision is the fourth global approval for efsitora in type 2 diabetes, following actions in the European Union, Mexico, and Japan.

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome

On September 25, 2026, the FDA approved obinutuzumab (Gazyva) to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. The decision makes obinutuzumab the first FDA-approved treatment option for idiopathic nephrotic syndrome in 70 years and was supported by data from the phase 3 INShore study showing a greater proportion of people experienced no relapses after week 8 and were in complete remission at one year with obinutuzumab (95%) compared with mycophenolate mofetil (73%).