HCPLive Editorial Staff

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) clearance of Medtronic’s MiniMed Go Smart Multiple Daily Injection app for use by pediatric and adult patients with type 1 diabetes or type 2 diabetes, the approvals of Neurolief’s ProlivRx brain neuromodulation therapy for adults with major depressive disorder (MDD) who did not respond to ≥ 1 antidepressant and Emergent BioSolutions’ supplemental New Drug Application (sNDA) for over-the-counter naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability, extension of the review timeline for Travere Therapeutics’ sNDA for sparsentan (Filspari) for focal segmental glomerulosclerosis (FSGS), and request to remove information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that include such language.

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 January 11, 2025—let’s jump in!

FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, the FDA granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes or type 2 diabetes aged ≥7 years, as well as for children between 2-6 years under adult supervision.

The MiniMed Go Smart MDI system integrates the InPen smart insulin pen with the Instinct sensor developed by Abbott, all of which are connected through the MiniMed Go app. The system provides users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to simplify dose decision-making.

FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

On January 12, 2026, the FDA approved Neurolief’s ProlivRx, the first at-home, physician-directed brain neuromodulation therapy for adults with MDD who did not respond to ≥ 1 antidepressant. The therapy can be delivered at home under physician supervision, eliminating the access and operational challenges of clinic-based treatments.

The approval was supported by clinical evidence from the MOOD Study, a randomized, controlled, multicenter clinical trial, evaluating ProlivRx in MDD with inadequate response to antidepressant medications.

FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA Therapies

On January 13, 2026, the FDA requested the removal of information regarding the risk of suicidal ideation and behavior (SI/B) from the labeling of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications that included such language. Affected products include liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound). The action follows a comprehensive FDA review that found no increased risk of SI/B associated with the use of GLP-1 RA medications.

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, Travere Therapeutics announced the FDA extension of the review timeline for the Company’s sNDA of sparsentan (Filspari) for FSGS. The Agency moved the Prescription Drug User Fee Act (PDUFA) target action date, which was expected on January 13, 2026, to April 13, 2026. No additional information relating to the safety or manufacturing of the drug was requested.

FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

On January 14, 2026, the FDA approved Emergent BioSolutions’ sNDA for over-the-counter (OTC) naloxone HCl Nasal Spray 4 mg (Narcan) to be packaged in a new carrying case to improve ease of transport and usability.

The new case includes 2 blister packs, each enclosed with Quick Start Guide, and is designed to be compact, discreet and durable, with the goal of making naloxone more readily carried and available. The new design aims to reduce the stigma often associated with carrying naloxone and to increase its rates of carry and chances of its use in emergencies.

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The FDA has recently cleared Medtronic's MiniMed Go Smart MDI app for pediatric and adult diabetes patients, enhancing insulin management. Neurolief's ProlivRx, an at-home neuromodulation device for major depressive disorder, received FDA approval, offering a new treatment avenue for patients unresponsive to antidepressants. The FDA also requested the removal of suicidal ideation warnings from GLP-1 RA therapies, citing no increased risk. Additionally, the FDA extended the review timeline for Travere Therapeutics' sparsentan for FSGS and approved new Narcan packaging to improve accessibility and usability.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and clearances, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 01/11

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 caplacizumab-yhdp (Cablivi) for pediatric patients ≥ 12 years of age with acquired thrombotic thrombocytopenic purpura (aTTP) and Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency, Priority Review designations for a BLA atacicept for the treatment of adults with IgA nephropathy (IgAN) and an sBLA for teplizumab-mzwv to expand the age indication from ≥8 years to ≥1 year, aiming to delay the onset of stage 3 type 1 diabetes, and Breakthrough Therapy Designation for pemvidutide for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH).

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 January 4, 2025—let’s jump in!

FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP Therapy

On January 5, 2026, the FDA approved Sanofi’s caplacizumab-yhdp (Cablivi) for injection to treat pediatric patients ≥ 12 years of age with aTTP in combination with plasma exchange and immunosuppressive therapy. The decision builds upon caplacizumab’s initial 2019 approval for adults with aTTP and was supported by efficacy data from a retrospective chart review study of 30 patients 2-18 years of age showing 80% of patients achieved clinical remission. Of note, the approval made caplacizumab the first treatment for pediatric aTTP.

Pemvidutide Gets Breakthrough Therapy Designation for MASH

On January 5, 2026, the FDA granted Breakthrough Therapy Designation (BTD) to Altimmune’s pemvidutide for the treatment of MASH based on 24-week data from the phase 2b IMPACT trial demonstrating statistically significant MASH resolution without worsening of fibrosis and early and substantial improvements in liver fat and non-invasive tests (NITs) of fibrosis and hepatic inflammation.

Altimmune has aligned with the FDA on the parameters for a planned registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis evaluating multiple pemvidutide doses over a 52-week treatment period and incorporating biopsy-based endpoints to support a potential accelerated approval and the use of AIM-MASH AI Assist, the first AI pathology tool qualified by the FDA for use in MASH clinical trials.

FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

On January 7, 2026, the FDA granted priority review to Vera Therapeutics’ Biologics License Application (BLA) for atacicept for the treatment of adults with IgAN. The BLA submission was supported by data from the phase 3 ORIGIN 3 trial’s prespecified interim analysis showing the trial met its primary endpoint for reduction in proteinuria at week 36, with a 46% reduction compared to baseline and a 42% reduction compared to placebo (

FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a 2-gram presentation of Octapharma’s Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. Initially approved as a 1-gram single-dose bottle in 2024, Fibryga is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the US. The updated kit also contains 100 mL of Water for Infusion and continues to feature the nextaro reconstitution device.

FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1D

On January 5, 2026, the FDA accepted for priority review the supplemental biologics license application (sBLA) for Sanofi’s teplizumab-mzwv to expand the age indication from ≥8 years to ≥1 year, aiming to delay the onset of stage 3 type 1 diabetes. The sBLA submission was based on positive interim one-year data from the ongoing PETITE-T1D phase 4 study, a 2 year single-arm, open-label, multicenter study of children <8 years with stage 2 T1D.

The FDA has approved caplacizumab-yhdp (Cablivi) for pediatric patients with aTTP, marking the first treatment for this age group. Pemvidutide received Breakthrough Therapy Designation for MASH, with promising phase 2b trial results. Atacicept's BLA for IgA nephropathy was granted priority review, supported by significant proteinuria reduction data. Fibryga's 2-gram presentation was approved for acquired fibrinogen deficiency, enhancing treatment options. Teplizumab's sBLA was accepted for priority review to expand its use in younger children with stage 2 type 1 diabetes, based on positive interim study data.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and other regulatory updates, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 01/04

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) 510(k) clearance of StimLabs’ Theracor for wound care, the approval of tradipitant (Nereus) for motion sickness, Complete Response Letters (CRL) for Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration, and the acceptance and Priority Review of Axsome Therapeutics’ supplemental New Drug Application for AXS-05 for the treatment of agitation in Alzheimer’s disease.

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 December 28, 2025—let’s jump in!

FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

On December 29, 2025, the FDA granted 510(k) clearance to StimLabs’ Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation. The clearance builds upon the Agency’s prior authorization of Corplex P, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format.

FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion

On December 30, 2025, the FDA approved Vanda Pharmaceuticals’ tradipitant under the brand name Nereus for the prevention of vomiting induced through motion sickness. The decision marked the first new pharmacologic treatment in motion sickness in more than 4 decades and was based on data from a pair of phase 3 trials, Motion Syros and Motion Serifos, showing lower vomiting and severe nausea with tradipitant versus placebo.

FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism

On December 31, 2025, the FDA issued a CRL to Corcept Therapeutics’ New Drug Application for relacorilant for hypercortisolism. While the Agency acknowledged the GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence, the FDA concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

FDA Issues Complete Response Letter for ONS-5010 for Wet AMD

On December 31, 2025, the FDA issued a CRL to Outlook Therapeutics’ ONS-5010 for the treatment of wet age-related macular degeneration. The latest CRL adds to 2 previous CRLs in ONS-5010’s lengthy regulatory road, with the FDA determining that the additional mechanistic and natural history data provided in the newest resubmission failed to alter the previous review conclusion, which stated that confirmatory evidence of efficacy must be submitted to support the application. At the time of the CRL, the FDA had not yet indicated what type of confirmatory evidence would be acceptable.

FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation

On December 31, 2025, the FDA accepted and granted Priority Review to Axsome Therapeutics’ supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation in Alzheimer’s disease, setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. The sNDA was supported by data from the comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including 4 randomized, double-blind, controlled phase 3 clinical trials and a long-term safety trial.

Hillenbrand A. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care. HCPLive. December 29, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-grants-510-k-clearance-first-umbilical-cord-derived-sheet-formulation-wound-care

Livingston R. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-approves-tradipitant-nereus-for-the-prevention-of-vomiting-induced-by-motion

Livingston R. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-relacorilant-for-hypercortisolism

Livingston R. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-issues-complete-response-letter-for-ons-5010-for-wet-amd

Livingston R. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation. HCPLive. December 31, 2025. Accessed January 2, 2025. 

https://www.hcplive.com/view/fda-accepts-grants-priority-review-to-axs-05-snda-for-alzheimer-s-disease-agitation

The FDA has granted 510(k) clearance to StimLabs’ Theracor, a novel umbilical cord-derived sheet for wound care. Tradipitant, branded as Nereus, received FDA approval for motion sickness, marking the first new treatment in over 40 years. Corcept Therapeutics’ relacorilant for hypercortisolism and Outlook Therapeutics’ ONS-5010 for wet AMD both received Complete Response Letters, requiring additional evidence. Axsome Therapeutics’ AXS-05 for Alzheimer’s agitation was accepted for Priority Review, with a target action date set for April 30, 2026.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and CRLs, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 12/28

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 approvals of lerodalcibep-liga (Lerochol) injection for adults with hypercholesterolemia, depemokimab-ulaa (Exdensur) as an add-on maintenance treatment for severe asthma, and fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, as well as Breakthrough Device Designation granted to to the Holly™ implantable, continuous dialysis system and positive topline results from a pair of phase 3 studies of zasocitinib in adults with moderate-to-severe plaque psoriasis (PsO).

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 December 14, 2025—let’s jump in!

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved LIB Therapeutics’ lerodalcibep-liga (Lerochol) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

The novel, third-generation PCSK9 inhibitor is self-administered as a once-monthly, single small-volume subcutaneous injection with extended room-temperature stability up to 3 months.

FDA Approves Depemokimab-ulaa (Exdensur) for Severe Asthma

On December 17, 2025, the FDA approved GSK’s depemokimab-ulaa (Exdensur) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients ≥ 12 years of age. The decision was based on data from the phase 3 SWIFT-1 and SWIFT-2 trials showing sustained exacerbation reduction with 2 doses per year versus placebo, both plus standard of care.

FDA Approves Fibrinogen, Human-chmt (Fesilty) for Congenital Fibrinogen Deficiency

On December 19, 2025, the FDA approved Grifols’ fibrinogen, human-chmt (Fesilty) for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. The product will be commercialized in the US by Grifols and is expected to be available during the first half of 2026.

FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

On December 15, 2025, the FDA granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system, recognizing Holly as a novel, transformative therapy addressing end-stage kidney disease. The designation was supported by data from a multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

On December 18, 2025, Takeda announced positive topline results from a pair of phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe PsO. The Latitude studies demonstrated superiority of zasocitinib compared to placebo for the coprimary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at week 16, with a significantly greater PASI 75 response rate observed as early as week 4 and continuing to increase through week 24. Of note, the studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.

The FDA has approved several new treatments, including lerodalcibep-liga for hypercholesterolemia, depemokimab-ulaa for severe asthma, and fibrinogen, human-chmt for congenital fibrinogen deficiency. Additionally, the Holly implantable dialysis system received Breakthrough Device Designation, highlighting its potential in treating end-stage kidney disease. Takeda's zasocitinib showed promising results in phase 3 trials for moderate-to-severe plaque psoriasis, demonstrating significant efficacy over placebo. These developments underscore ongoing advancements in therapeutic options across various medical conditions, offering new hope for patients and healthcare providers.

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