The HCPFive: Top News for Healthcare Providers from the Week of 10/05

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) approvals of roflumilast (Zoryve) cream 0.05% for the topical treatment of pediatric atopic dermatitis and nerandomilast 9 mg and 18 mg tablets (Jascayd) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) as well as new clinical trial data for mirikizumab-mrkz (Omvoh) in ulcerative colitis (UC), baxdrostat in treatment-resistant hypertension, and topical bimiralisib gel (2%) in actinic keratosis.

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 October 5, 2025—let’s jump in!

FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years

On October 6, 2025, the FDA approved Arcutis Biotherapeutics’ supplemental new drug application (sNDA) for roflumilast (Zoryve) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2-5 years of age. The decision was based on data from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study, representing the 6th FDA approval for the roflumilast portfolio in just over 3 years.

Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years

On October 7, 2025, the FDA approved Boehringer Ingelheim’s nerandomilast 9 mg and 18 mg tablets (Jascayd) for the treatment of adults with IPF, marking the first new approval for the disease in > 10 years.

“This milestone represents a new era in the treatment of IPF, a rare and debilitating chronic condition that worsens lung function. Nerandomilast has proven to slow lung function decline in IPF,” FIBRONEER-IPF investigator Toby Maher, MD, PhD, Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles, said in a statement. “Nerandomilast is a welcome new treatment option with a well-tolerated safety profile for physicians to consider for appropriate patients.”

LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years

On October 7, 2025, Eli Lilly and Company announced data from the phase 3 LUCENT-3 open-label extension study establishing mirikizumab-mrkz (Omvoh) as the first and only interleukin-23p19 to help patients with moderately to severely active UC achieve sustained, long-term outcomes through 4 years. Positive results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy.

Bax24: Baxdrostat Achieves Primary Endpoint in Treatment-Resistant Hypertension

On October 7, 2025, AstraZeneca announced data from the phase 3 Bax24 trial showing baxdrostat achieved the primary endpoint of a statistically significant reduction in ambulatory 24-hour average systolic blood pressure in patients with treatment-resistant hypertension. Full data from the trial will be shared with regulatory authorities and presented in a late-breaking session at the American Heart Association Scientific Sessions in November 2025.

Topical Bimiralisib Shows 92% Clearance Rate for Patients with Actinic Keratosis

On October 6, 2025, Torqur AG, announced full phase 2 proof-of-concept study results of topical bimiralisib gel (2%) for the treatment of actinic keratosis at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France. Findings showed high rates of clearance and a consistently favorable tolerability profile.