HCPLive Editorial Staff

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? 

Top 5 Healthcare Headlines for June 2-8, 2025.

FDA Approves Clesrovimab RSV Immunization for Newborns and Infants


The FDA has approved clesrovimab (Enflonsia) for the prevention of RSV lower respiratory tract disease in infants, based on results from two late-stage clinical trials evaluating its safety and efficacy.



FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV


The FDA has expanded the indication for glecaprevir/pibrentasvir to include treatment of acute hepatitis C virus infection in adults and children aged three years and older, regardless of cirrhosis status.



FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation


Prednisolone acetate ophthalmic suspension 1% has received FDA approval as a topical steroid treatment for steroid-responsive ocular inflammation, with product launch expected later in 2025.



FDA Grants Fast Track Designation to Mavorixafor for Chronic Neutropenia


The FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia, supporting its ongoing phase 3 evaluation following earlier approval for WHIM syndrome.



Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial


Phase 3 data show iptacopan (Fabhalta) is effective and well-tolerated in adults with PNH who transitioned from anti-C5 therapy, achieving key hematologic outcomes and symptomatic improvement.


Articles

The FDA has approved clesrovimab for RSV prevention in infants and expanded glecaprevir/pibrentasvir's indication to treat acute HCV in individuals aged three and older. Prednisolone acetate ophthalmic suspension has been approved for ocular inflammation, with a launch expected in 2025. Mavorixafor received Fast Track designation for chronic neutropenia, advancing its phase 3 evaluation. Iptacopan demonstrated efficacy and tolerability in a phase 3 trial for PNH, achieving significant hematologic outcomes and symptomatic improvement in patients transitioning from anti-C5 therapy.

An audio recap of the top 5 stories in healthcare news from the week of 06/02-06/08.



HCPLive 5 Stories in Under 5: Week of 06/08

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 a trio of US Food and Drug Administration approvals for clesrovimab (Enflonsia) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants, glecaprevir/pibrentasvir (Mavyret) for acute 

, and prednisolone acetate ophthalmic suspension for steroid-responsive ocular inflammation, as well as a Fast Track Designation for mavorixafor for the treatment of 

paroxysmal nocturnal hemoglobinuria (PNH)

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 June 8, 2025—let’s jump in!

One June 9, 2025, the FDA approved clesrovimab, under the name Enflonsia, for preventing RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. The decision was based on data from the pivotal phase 2b/3 CLEVER trial evaluating a single dose of clesrovimab administered to preterm and full-term infants (from birth to 1 year of age), as well as the phase 3 SMART trial evaluating the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease.

On June 11, 2025, the FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With this decision, glecaprevir/pibrentasvir is now approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis. Of note, the decision makes glecaprevir/pibrentasvir the first and only DAA therapy approved to treat patients with acute HCV in 8 weeks with a 96% cure rate.

On June 12, 2025, the FDA approved prednisolone acetate ophthalmic suspension, USP 1%, a sterile, topical anti-inflammatory agent, for the treatment of steroid-responsive ocular inflammation. It is a self-administered eye drop intended for use 2-4 times daily. During the first 24 hours of treatment, this frequency may be increased if necessary.

In addition to the approval, parent company Amneal Pharmaceuticals, Inc. announced a planned launch of the product for the third quarter of 2025.

On June 10, 2025, the FDA granted Fast Track designation to mavorixafor, an oral CXCR4 antagonist, for the treatment of 

. The agent is currently being examined in the ongoing phase 3 4WARD trial and was previously approved in 2024 for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections, and myelokathexis) in patients ≥12 years of age.

Positive results from APPULSE-PNH highlight the safety and efficacy of twice-daily oral monotherapy iptacopan (Fabhalta) in adults with PNH with hemoglobin (Hb) levels ≥10 g/dL who switched from the anti-C5 therapies eculizumab or ravulizumab.

Findings showed the vast majority of patients (92.7%) achieved Hb ≥12 g/dL, and none required transfusion during the study. Additionally, many patients treated with iptacopan also reported clinically meaningful improvements in fatigue. Novartis also noted maintenance of intravascular hemolysis control and resolved extravascular hemolysis control, demonstrated by lactate dehydrogenase levels and a reduction in absolute reticulocyte count. Iptacopan was well-tolerated and exhibited no new safety signals.

The recent FDA approvals and designations mark significant advancements in various therapeutic areas. Clesrovimab (Enflonsia) is now approved for RSV prevention in neonates and infants, while glecaprevir/pibrentasvir (Mavyret) has expanded its label to include acute HCV treatment. Prednisolone acetate ophthalmic suspension received approval for ocular inflammation, and mavorixafor gained Fast Track designation for chronic neutropenia. Additionally, iptacopan (Fabhalta) demonstrated efficacy in PNH patients, achieving primary endpoints in the phase 3 APPULSE-PNH trial, with notable improvements in hemoglobin levels and fatigue reduction.

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

The HCPFive: Top News for Healthcare Providers from the Week of 06/08

 editorial team publishes a new iteration of our Month in Review series, during which a summary provides several highlights of the most notable news coverage from the month in each medical subfield. Here, the team spotlights some of the most significant stories in the field of 

The dermatology space in May featured a set of notable 

) approvals—specifically roflumilast foam 0.3% for scalp and body psoriasis and a novel blue light device for actinic keratosis—as well as a variety of new data on treatments for such conditions as psoriasis and alopecia areata. The 2 regulatory milestones, along with emerging clinical research and expert commentary presented throughout the month, marked important steps forward in the management of chronic inflammatory and pre-cancerous skin conditions.

FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis

In 1 of the most notable FDA decisions announced in May, roflumilast (Zoryve) foam 0.3% was approved as a once-daily topical therapy for patients with plaque psoriasis who were adults or adolescents a(ged 12 years and older). Clinical data had demonstrated the drug’s efficacy in clearing plaques and providing rapid itch relief, with positive results in phase 2 and 3 analyses.

FDA Approves New Blue Light Tool for Actinic Keratosis

The FDA also approved the premarket application (PMA) for BLU-U Blue Light Photodynamic Therapy (PDT) Illuminators, which features light-emitting diode (LED) light panels rather than the fluorescent tubes implemented in prior models, for actinic keratosis. The May 16 approval announcement for Sun Pharma’s LED BLU-U model, used in combination with aminolevulinic acid HCl (KERASTICK) topical solution, 20%, included a reference to its indication for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, and upper extremities.

Study Supports Adalimumab Biosimilar Interchangeability for Patients with Psoriasis

Adalimumab biosimilar interchangeability was supported by findings reported on in May, along with data supporting the practice of non-medical switches between such biosimilars for those with psoriasis. These findings suggested that the most commonly registered reason for treatment discontinuation was a loss of effect.

New Phase 3 Data on Icotrokinra Suggest Efficacy for Genital, Scalp Psoriasis

Phase 3 data announced in May, released by Protagonist Therapeutics, Inc., showed that icotrokinra—an oral peptide designed to selectively inhibit the interleukin (IL)-23 receptor— for psoriasis resulted in 66% of individuals with scalp psoriasis and 77% of those with genital psoriasis achieving site-specific clear or almost clear skin at the 16-week mark.

Roflumilast Foam 0.3% for Scalp, Body Psoriasis Effective, Safe for Patients

Data from the phase 3 ARRECTOR study demonstrated that roflumilast foam 0.3% showed significant efficacy in treating patients with scalp and body psoriasis, with many of those treated achieving rapid symptom relief and high success rates in their clinical assessments. The phase 3 study involved 432 subjects, demonstrating the foam's safety and tolerability with low adverse event rates.

Azathioprine Effective for Patients with Recalcitrant, Severe Alopecia Areata

Additional findings announced in May suggested that azathioprine was an efficacious systemic drug for those living with recalcitrant and severe alopecia areata, with significant efficacy observed and a mean hair regrowth of 92.69% noted over the course of 10 years. The analysis involved 63 participants, with baseline evaluations and regular monitoring done to ensure safety and efficacy.

Systemic Corticosteroids Enhance Baricitinib’s Efficacy for Alopecia Areata

In another story highlighted from May, findings indicated that systemic corticosteroids, along with baricitinib, enhanced the treatment’s efficacy for those living with severe alopecia areata and result in sustained benefits. This was especially observed among partial responders.

May's dermatology advancements included significant FDA approvals and new clinical data. Roflumilast foam 0.3% was approved for scalp and body psoriasis, demonstrating efficacy in plaque clearance and itch relief. A novel blue light device for actinic keratosis also received approval. New studies supported adalimumab biosimilar interchangeability for psoriasis and highlighted icotrokinra's efficacy for genital and scalp psoriasis. Roflumilast foam showed safety and effectiveness in phase 3 trials. Azathioprine proved effective for severe alopecia areata, while systemic corticosteroids enhanced baricitinib's efficacy for the condition.

This Month in Review summary includes a list of some of the most notable or impactful news in the dermatology field from May 2025.

Dermatology Month in Review: May 2025

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 

 approval of a new dry eye disease (DED) drug, a first-of-its-kind oral hydrocortisone solution for adrenal insufficiency, the failure of a Phase 3 trial for AL amyloidosis, a Priority Review granted for IgA nephropathy (IgAN), and new surgical guidelines for treating chronic rhinosinusitis.

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 May 18, 2025—let’s jump in!

FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease

The FDA approved acoltremon ophthalmic solution .003% (TRYPTYR), formerly AR-15512, a first-in-class transient receptor potential melastatin 8 channel (TRPM8) receptor agonist that stimulates corneal sensory nerves, to treat signs and symptoms of DED. Approval was awarded to Alcon based on positive data from two Phase 3 clinical trials, COMET-2 and COMET-3, analyzing more than 930 patients with DED.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

The FDA approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency. Awarded to Eton Pharmaceuticals, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have special requirements.

Birtamimab Misses Primary Phase 3 Endpoint for AL Amyloidosis

Birtamimab missed the primary endpoint in the Phase 3 AFFIRM-AL clinical trial for the treatment of AL amyloidosis, resulting in the discontinuation of development and the halt of the open-label extension. As a result, Prothena Corporation announced plans to cut operating costs and significantly shrink its workforce, with further details on the matter expected in June.

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

The FDA accepted and granted Priority Review to the Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN. Supported by positive data from the Phase 3 VISIONARY trial, the BLA was assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2025.

New Guidelines Outline When to Consider Sinus Surgery for Chronic Rhinosinusitis

The American Academy of Otolaryngology-Head and Neck Surgery Foundation released new clinical practice guidelines for the surgical management of 

 The guidelines, targeted for otolaryngologist-head and neck surgeons who manage adults with chronic rhinosinusitis, provided 11 evidence-based key action statements to inform the main surgery options for chronic sinus problems and additional treatments or follow-up procedures.

The latest healthcare updates include the FDA's approval of acoltremon ophthalmic solution for dry eye disease and a new oral hydrocortisone solution for adrenal insufficiency. Birtamimab failed to meet the primary endpoint in a Phase 3 trial for AL amyloidosis, leading to halted development. The FDA granted Priority Review to sibeprenlimab for IgA nephropathy, with a target action date set. New guidelines for chronic rhinosinusitis surgery were released, providing evidence-based recommendations for otolaryngologists managing adult patients with this condition.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and new treatment guidelines, in this week's essential news roundup.