HCPLive Podcasts

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!Top 5 Healthcare Headlines for January 18-24, 2025:1. Phase 2 Data Show NS002 Intranasal Epinephrine Acts Faster Than EpiPenInterim phase 2 data suggest NS002 intranasal epinephrine may provide more rapid systemic exposure than intramuscular autoinjectors, supporting its potential as a needle-free option for anaphylaxis management.2. AHA 2026 Heart Disease and Stroke Statistics: Progress and Pitfalls, With Latha Palaniappan, MD, MSThe AHA’s 2026 Heart Disease and Stroke Statistics highlight persistent gaps in cardiovascular prevention and outcomes despite advances in treatment, with continued emphasis on heart disease and stroke as leading causes of mortality in the US.3. New CHEST Recommendations Guide Biologic Use for Severe AsthmaCHEST released updated guidance to help clinicians individualize biologic selection for severe asthma based on patient characteristics, disease phenotype, and available evidence.4. Topical Steroid Concerns in Dermatology Highlighted in Nationwide SurveyA nationwide survey underscores widespread patient and caregiver concerns about long-term topical steroid use in chronic inflammatory skin diseases and a perception that current management strategies are largely reactive rather than preventive.5. Amlitelimab Effective, Safe for Atopic Dermatitis in Patients 12 Years and OlderPhase 3 data show amlitelimab was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis, supporting its role as a targeted, non–T-cell-depleting biologic option.

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!Top 5 Healthcare Headlines for January 11-17, 2025:1. FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2DThe FDA cleared Medtronic’s MiniMed Go Smart MDI app for pediatric and adult patients with type 1 or type 2 diabetes, enabling integrated smart pen and sensor–based decision support to improve insulin dosing with multiple daily injections.2. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDDThe FDA approved ProlivRx as the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded adequately to antidepressant treatment.3. FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA TherapiesThe FDA requested removal of suicidal ideation and behavior warnings from GLP-1 receptor agonist labels after determining there is no increased risk associated with these therapies.4. FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental GlomerulosclerosisThe FDA extended the review timeline for sparsentan’s supplemental NDA in focal segmental glomerulosclerosis, delaying the PDUFA decision without requesting additional safety or manufacturing data.5. FDA Approves New Narcan Packaging, Aiming to Boost Carry RatesThe FDA approved new, more portable packaging for over-the-counter Narcan nasal spray to improve usability, reduce stigma, and increase the likelihood that naloxone is carried and available during overdose emergencies.

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!Top 5 Healthcare Headlines for January 3-10, 2025:Here are one-sentence, clinician-focused summaries with titles restated and no statistics included:1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP TherapyThe FDA approved caplacizumab for adolescents with aTTP, making it the first therapy specifically indicated for pediatric patients with this condition.2. Pemvidutide Gets Breakthrough Therapy Designation for MASHThe FDA granted Breakthrough Therapy Designation to pemvidutide for MASH, supporting its accelerated development based on promising mid-stage clinical data and alignment on a registrational phase 3 program.3. FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA NephropathyThe FDA granted Priority Review to the BLA for atacicept, advancing a potential new biologic therapy for adults with IgA nephropathy.4. FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen DeficiencyThe FDA approved a higher-dose presentation of Fibryga, expanding dosing flexibility for fibrinogen replacement in patients with acquired fibrinogen deficiency.5. FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1DThe FDA accepted a Priority Review sBLA for teplizumab to expand its use to younger children in order to delay progression to clinical type 1 diabetes.

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! Top 5 Healthcare Headlines for December 28-January 3, 2025: 1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation. 2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting. 3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials. 4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application. 5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.

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! Top 5 Healthcare Headlines for October 12-18, 2025: 1. FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes 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. 2. FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD The FDA broadened upadacitinib’s indication to allow use in ulcerative colitis and Crohn disease when tumor necrosis factor blockers are not clinically appropriate. 3. FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology The FDA cleared Elecsys pTau181 as the first blood test to help rule out Alzheimer-related amyloid pathology in older adults with cognitive symptoms. 4. Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial A phase 3 study showed a prescription digital therapeutic significantly reduced negative symptoms in schizophrenia when used alongside antipsychotic therapy. 5. APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint 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! Top 5 Healthcare Headlines for October 5-11, 2025: 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! Top 5 Healthcare Headlines for September 28-October 4, 2025: FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis The FDA approved guselkumab as the first IL-23 inhibitor for children ≥6 years with moderate-to-severe plaque psoriasis or active psoriatic arthritis. FDA Approves Remibrutinib for Chronic Spontaneous Urticaria Remibrutinib, a selective BTK inhibitor, gained FDA approval for adults with chronic spontaneous urticaria based on sustained efficacy in phase 3 trials. Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes Novo Nordisk resubmitted its once-weekly insulin icodec BLA for type 2 diabetes after addressing prior FDA concerns. Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A Novo Nordisk filed a BLA for denecimig as prophylaxis for hemophilia A, supported by FRONTIER program data. VESALIUS-CV: Evolocumab (Repatha) Achieves Primary Endpoints in Patients with ASCVD 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! Top 5 Healthcare Headlines for September 5-September 14, 2025: 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! Top 5 Healthcare Headlines for August 31-September 5, 2025: 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. FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD The FDA issued a complete response letter for ONS-5010 in wet AMD, citing insufficient efficacy evidence from the phase 3 program. ACC Releases Respiratory Disease Vaccination Guidelines for Adults with Heart Disease The ACC released new guidance recommending vaccination against respiratory infections for adults with cardiovascular disease to improve prevention and access. Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial 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! Top 5 Healthcare Headlines for August 17-23, 2025: 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! Top 5 Healthcare Headlines for August 10-16, 2025: 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! Top 5 Healthcare Headlines for August 3-9, 2025: FDA Approves Fremanezumab to Prevent Episodic Migraine in Children 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. Oral Berotralstat Shows Strong Safety, Efficacy in Young Children with HAE 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.

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! Top 5 Healthcare Headlines for July 7-13, 2025: FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More Finerenone (Kerendia) was approved on July 14, 2025, to reduce cardiovascular death and heart failure hospitalizations in adults with HFmrEF or HFpEF, based on data from the FINEARTS-HF trial. Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension In the phase 3 BaxHTN trial, baxdrostat significantly reduced systolic blood pressure in patients with resistant hypertension, supporting its potential as a first-in-class aldosterone synthase inhibitor. FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease The FDA approved an updated irrigation flow rate for the VARIPULSE Platform, which has been used in over 10,000 procedures with a reported neurovascular adverse event rate of less than 0.5%. Palopegteriparatide Provides Sustained Response in Adults with Hypoparathyroidism Palopegteriparatide showed durable 3-year improvements in biochemistries, kidney function, and quality of life across all forms of hypoparathyroidism in the phase 3 PaTHway trial. FDA Grants Orphan Drug Designation to Taladegib, Potential Idiopathic Pulmonary Fibrosis Treatment Taladegib received Orphan Drug Designation on July 16, 2025, as a potential treatment for idiopathic pulmonary fibrosis, currently being studied in the phase 2b WHISTLE-PF trial.

In this episode, hosts Kimberly Brown, MD, and Nancy Reau, MD, discuss the progress and persistent challenges in eliminating hepatitis C (HCV). With highly effective, short-course oral therapies now available, Brown and Reau emphasize that curing HCV is more achievable than ever. The discussion explores the major policy, clinical, and structural milestones enabling this effort—and the critical gaps in diagnosis, treatment access, and health policy that still impede progress.

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! Top 5 Healthcare Headlines for June 30-July 6, 2025: Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema The FDA approved sebetralstat (Ekterly) on July 7, 2025, as the first oral, on-demand treatment for hereditary angioedema attacks in patients aged 12 and older, backed by phase 3 KONFIDENT trial data. Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial Rilparencel significantly slowed kidney function decline in CKD patients with diabetes in the REGEN-007 trial, showing dose-responsive eGFR slope improvements after two injections per kidney. J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse J&J filed a supplemental NDA for lumateperone after phase 3 data showed a 63% reduction in schizophrenia relapse risk compared to placebo. FDA Publishes CRLs for Past Drug, Biological Product Applications The FDA publicly released over 200 Complete Response Letters from 2020–2024 to increase regulatory transparency and help accelerate future drug approvals. FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD TSND-201 (methylone) received Breakthrough Therapy designation for PTSD on July 10, 2025, offering a potential rapid-acting alternative to SSRIs, which can take up to 12 weeks for full effect.