Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

The FDA accepted MannKind’s sBLA for Afrezza inhaled insulin to expand its use to children and adolescents with type 1 or type 2 diabetes.

The FDA broadened upadacitinib’s indication to allow use in ulcerative colitis and Crohn disease when tumor necrosis factor blockers are not clinically appropriate.

The FDA cleared Elecsys pTau181 as the first blood test to help rule out Alzheimer-related amyloid pathology in older adults with cognitive symptoms.

A phase 3 study showed a prescription digital therapeutic significantly reduced negative symptoms in schizophrenia when used alongside antipsychotic therapy.

Iptacopan demonstrated meaningful efficacy in slowing kidney function decline in adults with IgA nephropathy, supporting future regulatory submissions.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

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

The FDA approved roflumilast cream 0.05% for mild to moderate atopic dermatitis in children aged 2–5 years, expanding Arcutis’ roflumilast portfolio.

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

Nerandomilast became the first newly approved therapy for idiopathic pulmonary fibrosis in over a decade, offering a well-tolerated option that slows lung function decline.

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

Long-term data confirmed mirikizumab provides durable clinical, endoscopic, and quality-of-life benefits for ulcerative colitis up to four years, even in patients who failed prior advanced therapy.

4. Bax24: Baxdrostat Achieves Primary Endpoint in Treatment-Resistant Hypertension

Baxdrostat met its primary endpoint in a phase 3 trial for treatment-resistant hypertension, supporting its potential role as a new option for difficult-to-control blood pressure.

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

Phase 2 data showed topical bimiralisib achieved high lesion clearance with favorable tolerability in patients with actinic keratosis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

The FDA approved guselkumab as the first IL-23 inhibitor for children ≥6 years with moderate-to-severe plaque psoriasis or active psoriatic arthritis.

Remibrutinib, a selective BTK inhibitor, gained FDA approval for adults with chronic spontaneous urticaria based on sustained efficacy in phase 3 trials.

Novo Nordisk resubmitted its once-weekly insulin icodec BLA for type 2 diabetes after addressing prior FDA concerns.

Novo Nordisk filed a BLA for denecimig as prophylaxis for hemophilia A, supported by FRONTIER program data.

Evolocumab reduced major cardiovascular events in ASCVD patients without prior MI or stroke in the phase 3 VESALIUS-CV trial.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

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

The FDA determined no advisory committee is needed for sparsentan’s sNDA in FSGS, which remains under review with a January 2026 decision date.

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

Intercept will withdraw obeticholic acid from the US PBC market after an FDA request and related clinical trial holds.

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

The FDA accepted a proposal to qualify FibroScan liver stiffness measurement as a surrogate endpoint for MASH trials, supported by multiple industry partners.

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

eGenesis received FDA clearance to begin clinical testing of a genetically engineered porcine kidney transplant in patients with ESKD.

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

Regeneron reported phase 3 success for novel allergen-blocking antibodies targeting cat and birch allergies, with confirmatory trials planned.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

1. Mitapivat PDUFA for Thalassemia Delayed to December 

The FDA extended the review timeline for mitapivat in thalassemia, with a new decision date set for December 2025.

2. Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years

Arcutis submitted an sNDA seeking to expand roflumilast cream’s indication to include plaque psoriasis in children as young as 2.

3. Zilebesiran, RNAi for Hypertension, Heads to Phase 3 Cardiovascular Outcomes Trial

Alnylam is advancing zilebesiran into a phase 3 outcomes trial to evaluate its impact on cardiovascular risk in patients with uncontrolled hypertension.

4. RestorAATion-2: WVE-006 Achieves Durable Serum AAT Protein Production in AATD

Wave Life Sciences reported durable serum AAT protein production with WVE-006 in AATD, supporting its potential for disease modification.

5. Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis

Sanofi announced phase 3 results showing amlitelimab improved disease severity and skin clearance in moderate-to-severe atopic dermatitis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia 

The FDA accepted a priority review application for omidubicel, a cell therapy under investigation for severe aplastic anemia.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy 

The FDA approved an updated REMS label for sparsentan, easing monitoring requirements for patients with IgA nephropathy.

The FDA issued a complete response letter for ONS-5010 in wet AMD, citing insufficient efficacy evidence from the phase 3 program.

The ACC released new guidance recommending vaccination against respiratory infections for adults with cardiovascular disease to improve prevention and access.

Eli Lilly reported phase 3 results showing orforglipron improved weight and glycemic control in adults with obesity or overweight and type 2 diabetes.

In this podcast, expert Suneel Udani, MD, discusses the management of chronic kidney disease (CKD) and CKD-associated fluid overload, including an overview of treatment guidelines and various available therapies.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

1. FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

The FDA approved donidalorsen (DAWNZERA) for preventing HAE attacks in patients 12 years and older, supported by phase 3 OASIS trial data.

2. FDA Grants Atumelnant Orphan Drug Designation for Congenital Adrenal Hyperplasia

Atumelnant received FDA Orphan Drug Designation after phase 2 results showed rapid, sustained reductions in key biomarkers for congenital adrenal hyperplasia.

3. Semaglutide Reduces Medical Costs, Healthcare Resource Utilization in Heart Failure

A real-world analysis found semaglutide 2.4 mg reduced all-cause medical costs by 28% and inpatient hospitalization costs by 55% in patients with obesity and heart failure.

4. RE104 Reduces Postpartum Depression Symptoms by Day 7 in Phase 2 RECONNECT

RE104 significantly reduced depressive symptoms by day 7 in patients with postpartum depression, meeting the phase 2 RECONNECT trial’s primary endpoint.

5. Dyslipidemia, Other Metabolic Syndrome Factors May Raise Parkinson’s Disease Risk

People with metabolic syndrome had about a 40% higher risk of developing Parkinson’s disease compared with those without the condition.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

FDA Approves 2 Generic Iron Sucrose Injections for Iron Deficiency Anemia in CKD 

The FDA approved 2 generic versions of iron sucrose injection for treating iron deficiency anemia in patients with CKD, expanding access to therapy.

FDA Approves PharmaTher’s Ketamine for Surgical Pain Management 

The FDA approved PharmaTher’s ketamine formulation for surgical pain management following resolution of earlier application deficiencies.

HFSA and ASPC Release Statement on Shifting to Prevention in Heart Failure 

The HFSA and ASPC issued a joint statement urging clinicians to prioritize prevention and early risk management in heart failure care.

Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis 

The FDA approved zopapogene imadenovec as the first immunotherapy for recurrent respiratory papillomatosis, offering a new treatment option.

AHA & ACC Release New Guidelines for High Blood Pressure to Reduce CVD Risk 

The AHA and ACC released updated hypertension guidelines recommending earlier intervention to lower cardiovascular disease risk.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

The FDA has expanded fremanezumab’s indication to include pediatric patients 6–17 years old, making it the first CGRP antagonist approved for preventing episodic migraine in this population.

ATTAIN-1: Orforglipron Achieves Up to 12% Weight Loss in Phase 3 Obesity Trial 

Orforglipron, an investigational oral GLP-1 receptor agonist, met all primary and secondary endpoints in phase 3, supporting its potential as a weight-management therapy.

Interim phase 3 data support oral berotralstat as a safe and effective prophylactic therapy for hereditary angioedema in children aged 2–11 years.

Aflibercept 8mg Noninferior to Aflibercept 2mg in Diabetic Macular Edema 

Aflibercept 8 mg demonstrated noninferior visual acuity outcomes to 2 mg dosing in DME, with potential for reduced injection frequency.

Despite Advances, IBS Continues to Impact Patients' Daily Lives, Productivity 

A new national survey reveals ongoing quality-of-life and productivity burdens among IBS patients despite greater awareness and expanded treatment options.