HCPLive Editorial Staff

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) acceptance of a supplemental biologics license application (sBLA) seeking approval for insulin human (Afrezza) Inhalation Powder in children and adolescents living with 

, approval of a supplemental new drug application (sNDA) updating the indication statement for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely 

active ulcerative colitis (UC) and Crohn’s disease (CD)

, and clearance of the Elecsys pTau181 test for ruling out 

-related amyloid pathology, as well as phase 3 data demonstrating the benefits of a prescription digital therapeutic for 

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 12, 2025—let’s jump in!

FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes

On October 13, 2025, MannKind Corporation announced the FDA acceptance of the sBLA seeking approval for insulin human (Afrezza) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application is supported by results from the phase 3, 26-week, open-label INHALE-1 study and, with the acceptance, has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.

FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD

On October 13, 2025, the FDA approved a supplemental new drug application (sNDA) updating the indication statement for AbbVie’s upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active UC and CD. The new statement allows the use of upadacitinib after patients have received ≥ 1 approved systemic therapy in the event tumor necrosis factor blockers are clinically inadvisable. Previously, upadacitinib was only indicated for adults who had an inadequate response or intolerance to ≥ 1 blockers.

FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology

The FDA cleared the Elecsys pTau181 test, the first blood test to rule out Alzheimer-related amyloid pathology. Intended for patients aged ≥ 55 years with presenting Alzheimer Disease symptoms, the test can assist the initial assessment for Alzheimer Disease and other causes of cognitive decline in the primary care setting.

Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial

On October 13, 2025, Boehringer Ingelheim and Click Therapeutics announced phase 3 data showing their investigational prescription digital therapeutic, used as an adjunct to antipsychotic therapy, significantly reduced experiential negative symptoms in patients with schizophrenia. The data were presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam.

APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint

On October 16, 2025, Novartis announced positive final results from the phase 3 APPLAUSE-IgAN study of iptacopan (Fabhalta) in adults with IgAN. In the trial, the oral alternative complement pathway inhibitor demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over 2 years. Of note, Novartis plans to use these data to support regulatory submissions for iptacopan in 2026.

MannKind. MannKind Announces U.S. FDA Accepts for Review its Supplemental Biologics License Application (sBLA) for Inhaled Insulin (Afrezza) in Children and Adolescents Aged 4-17 Years Living with Diabetes. October 13, 2025. Accessed October 17, 2025. 

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental

AbbVie. U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease. October 13, 2025. Accessed October 17, 2025. 

https://news.abbvie.com/2025-10-13-U-S-Food-and-Drug-Administration-FDA-Approves-Updated-Indication-Statement-for-RINVOQ-R-upadacitinib-for-the-Treatment-of-Inflammatory-Bowel-Disease

Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology. Diagnostics. Published October 6, 2025. Accessed October 17, 2025. 

https://diagnostics.roche.com/us/en/news-listing/2025/fda-cleared-ptau181-alzheimers-blood-test.html

Boehringer. Boehringer and Click Therapeutics present pivotal data for investigational prescription digital therapeutic CT-155 showing a statistically significant reduction in negative symptoms of schizophrenia. Prnewswire.com. Published October 13, 2025. Accessed October 17, 2025. 

https://www.prnewswire.com/news-releases/boehringer-and-click-therapeutics-present-pivotal-data-for-investigational-prescription-digital-therapeutic-ct-155-showing-a-statistically-significant-reduction-in-negative-symptoms-of-schizophrenia-302582119.html

Novartis. Novartis Fabhalta® (iptacopan) meets Phase III primary endpoint, slows kidney function decline in patients with IgA nephropathy (IgAN). October 16, 2025. Accessed October 17, 2025. 

https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-meets-phase-iii-primary-endpoint-slows-kidney-function-decline-patients-iga-nephropathy-igan

Articles

Recent developments in healthcare include FDA acceptance of a supplemental biologics license application for Afrezza Inhalation Powder for pediatric diabetes, and approval of an updated indication for upadacitinib in inflammatory bowel disease. The FDA also cleared the Elecsys pTau181 test for ruling out Alzheimer-related amyloid pathology. Additionally, phase 3 data showed a digital therapeutic reduced negative symptoms in schizophrenia, and iptacopan demonstrated efficacy in slowing IgA nephropathy progression. These advancements highlight significant progress in treatment options and diagnostic tools across various medical conditions.

Stay updated with the latest healthcare breakthroughs, including FDA updates and phase 3 trial readouts, in this week's essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 10/12

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 

 and nerandomilast 9 mg and 18 mg tablets (Jascayd) for the treatment of adults with 

 as well as new clinical trial data for mirikizumab-mrkz (Omvoh) in 

, 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.

The recent FDA approvals and clinical trial data highlight significant advancements in dermatology, pulmonology, gastroenterology, cardiology, and dermatological oncology. Roflumilast cream has been approved for pediatric atopic dermatitis, while nerandomilast tablets mark a breakthrough for idiopathic pulmonary fibrosis after a decade. Mirikizumab demonstrates sustained benefits in ulcerative colitis, and baxdrostat shows promise in treatment-resistant hypertension. Additionally, bimiralisib gel exhibits a high clearance rate for actinic keratosis. These developments underscore the ongoing innovation and progress in addressing complex medical conditions across various specialties.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and clinical trial readouts, in this week's essential news roundup.

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

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 guselkumab (Tremfya) for pediatric 

), 2 regulatory submissions from Novo Nordisk for insulin icodec (Awiqli) injection for 

 and denecimig (Mim8) for hemophilia A, and phase 3 data for evolocumab (Repatha) in patients with 

atherosclerotic cardiovascular disease (ASCVD)

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 28, 2025—let’s jump in!

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved Johnson & Johnson’s guselkumab (Tremfya) for the treatment of children ≥ 6 years of age who also weigh ≥ 40 kg (88 lbs) with moderate to severe PsO, who are candidates for systemic therapy or phototherapy, or active PsA. The decision makes guselkumab the first and only IL-23 inhibitor approved for these pediatric indications.

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria

On September 30, 2025, the FDA approved Novartis’ remibrutinib (Rhapsido), a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, for adults with CSU. The decision was supported by data from the phase 3 REMIX-1 and REMIX-2 trials showing that remibrutinib produced early and substantial reductions in CSU symptoms, with improvements sustained for up to 52 weeks.

Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes

On September 29, 2025, Novo Nordisk announced the resubmission of its Biologics License Application (BLA) to the FDA for insulin icodec (Awiqli) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program and follows a July 2024 CRL over concerns regarding the manufacturing process and the type 1 diabetes indication.

Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A

On September 29, 2025, Novo Nordisk announced the submission of a Biologics License Application (BLA) for denecimig (Mim8) as a prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital FVIIIa deficiency), with or without inhibitors. The submission was supported by results from the FRONTIER study program.

VESALIUS-CV: Evolocumab (Repatha) Achieves Primary Endpoints in Patients with ASCVD

On October 2, 2025, Amgen announced positive results from the phase 3 VESALIUS-CV trial of evolocumab (Repatha) in patients with ASCVD and no prior history of 

. The trial met its dual primary endpoints for time to first occurrence of a composite of heart attack, ischemic stroke, and coronary heart disease (CHD) death, as well as time to first occurrence of a composite of CHD death, ischemic stroke, heart attack, or any ischemia-driven arterial revascularization.

The FDA has approved guselkumab (Tremfya) for pediatric plaque psoriasis and psoriatic arthritis, marking it as the first IL-23 inhibitor for these indications. Remibrutinib (Rhapsido) has also been approved for chronic spontaneous urticaria, demonstrating significant symptom reduction. Novo Nordisk resubmitted its BLA for insulin icodec (Awiqli) for type 2 diabetes and submitted a BLA for denecimig (Mim8) for hemophilia A. Evolocumab (Repatha) achieved primary endpoints in the VESALIUS-CV trial for patients with atherosclerotic cardiovascular disease.

Stay updated with the latest healthcare breakthroughs, including FDA news, regulatory submissions, and evolocumab data for ASCVD, in this week's essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 09/28

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) removal of an advisory committee requirement for the supplemental New Drug Application (sNDA) for sparsentan (Filspari) in 

focal segmental glomerulosclerosis (FSGS)

, Intercept Pharmaceuticals’ voluntary withdrawal of obeticholic acid (Ocaliva) from the US market, the FDA’s acceptance of a Letter of Intent for the qualification of FibroScan as a reasonably likely surrogate endpoint in clinical trials for 

metabolic dysfunction-associated steatohepatitis (MASH)

, the Agency’s clearance of a clinical trial evaluating a genetically engineered porcine-derived kidney in patients with 

, and positive data for Regeneron’s first-in-class investigational 

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 7, 2025—let’s jump in!

FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

On September 10, 2025, Travere Therapeutics announced that the FDA informed the Company that following further review of the sNDA for sparsentan (Filspari) in FSGS, an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, sparsentan would be the first medication indicated for FSGS.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market

On September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid (Ocaliva) from the US market for the treatment of PBC following a request from the FDA.The Agency has placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.

FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials

On September 8, 2025, the FDA’s Center for Drug Evaluation and Research, Office of New Drugs accepted Echosense’ Letter of Intent for the qualification of Liver Stiffness Measurement (LSM) by Vibration-Controlled Transient Elastography (VCTE; FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH. The Letter of Intent included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD

On September 8, 2025, eGenesis announced the FDA clearance of its IND application to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with ESKD. The IND supports a phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.

First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials

On September 8, 2025, Regeneron Pharmaceuticals announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge phase 3 trials in adults with moderate-to-severe cat or birch allergies. Both trials met their respective primary and key secondary endpoints. Data from the phase 3 trials will be presented at an upcoming medical conference and will inform confirmatory phase 3 trials.

Travere Therapeutics' sparsentan (Filspari) for FSGS is under FDA review without an advisory committee, with a PDUFA date set for January 2026. Intercept Pharmaceuticals has withdrawn obeticholic acid (Ocaliva) for PBC from the US market following FDA's request. The FDA accepted a Letter of Intent for FibroScan as a surrogate endpoint in MASH trials. eGenesis received FDA clearance for a clinical trial of a genetically engineered pig kidney for ESKD. Regeneron's allergen-blocking antibodies showed positive results in phase 3 trials for cat and birch allergies.

Stay updated with the latest healthcare breakthroughs, including FDA news and the voluntary withdrawal of obeticholic acid, in this week's essential news roundup.