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 August 17-23, 2025:

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.

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.

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.

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.

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.

Articles

The recent healthcare updates include the FDA's approval of donidalorsen for preventing hereditary angioedema attacks in patients aged 12 and older, based on phase 3 OASIS trial data. Atumelnant received Orphan Drug Designation for congenital adrenal hyperplasia after promising phase 2 results. Semaglutide was found to significantly reduce medical costs and hospitalizations in heart failure patients. RE104 showed efficacy in reducing postpartum depression symptoms by day 7. Additionally, metabolic syndrome factors, including dyslipidemia, may increase the risk of developing Parkinson’s disease by approximately 40%.

An audio recap of the top 5 stories in healthcare news from the week of 08/17-08/



HCPLive 5 Stories in Under 5: Week of 08/17

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) approval of Ionis Pharmaceuticals’ donidalorsen (DAWNZERA) for 

 attack prevention, Orphan Drug Designation granted to Crinetics Pharmaceuticals’ atumelnant for the treatment of 

, real-world data on semaglutide’s impact on healthcare resource utilization in the context of 

, and research suggesting a link between 

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 August 17, 2025—let’s jump in!

On August 21, 2025, the FDA approved Ionis Pharmaceuticals’ donidalorsen (DAWNZERA), an RNA-targeted medicine, to prevent HAE attacks in adults and children aged 12 years or older. The decision follows an Orphan Drug Designation in 2023 and is supported by pivotal data from the phase 3 OASIS-HAE and OASISplus trials, along with findings from the ongoing phase 2 OLE trial.

On August 21, 2025, the FDA granted Orphan Drug Designation to Crinetics Pharmaceuticals’ atumelnant, an investigative treatment for congenital adrenal hyperplasia, based on positive topline results from the phase 2 TouCAHn trial demonstrating rapid, substantial, and sustained reductions in key biomarkers across all doses, including up to an 80% mean reduction in androstenedione.

Findings from a real-world analysis of Komodo Healthcare Map data suggest use of semaglutide 2.4 mg incurs lower medical costs and inpatient resource utilization among patients with overweight or obesity and heart failure compared with those who did not receive the GLP-1 receptor agonist. Specifically, semaglutide treatment was associated with 28% lower all-cause medical costs, 55% lower inpatient hospitalization costs, and 42% lower inpatient visit rate, a key driver of the lower costs observed with semaglutide.

On August 19, 2025, Reunion Neuroscience announced the phase 2 RECONNECT trial met its primary endpoint, with RE104 providing a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to day 7 in patients with postpartum depression.

“Despite its prevalence and severity, current treatment options for PPD remain limited and are often slow-acting and burdensome, leaving many new mothers without timely, effective care,” said lead investigator Anita H. Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry and Neurobehavioral Sciences at the University of Virginia School of Medicine, in a statement.

A larger waistline and higher blood pressure, among other factors connected to metabolic syndrome, may be associated with an increased risk of Parkinson disease, according to findings from a recent study. After adjusting for age, smoking status, physical activity and genes that increase the risk of Parkinson disease, investigators found people with metabolic syndrome were about 40% more likely to develop Parkinson’s disease than those without the syndrome.

The recent healthcare developments include the FDA's approval of donidalorsen for hereditary angioedema attack prevention and the Orphan Drug Designation for atumelnant in congenital adrenal hyperplasia. Real-world data highlights semaglutide's cost-effectiveness in heart failure management. The phase 2 RECONNECT trial shows RE104's efficacy in reducing postpartum depression symptoms. Additionally, research indicates a potential link between metabolic syndrome factors, such as dyslipidemia and increased waistline, and a heightened risk of Parkinson's disease, emphasizing the need for further investigation into these associations.

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

The HCPFive: Top News for Healthcare Providers from the Week of 08/17

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.


The FDA has approved two generic iron sucrose injections for iron deficiency anemia in CKD patients, enhancing treatment accessibility. PharmaTher's ketamine formulation received FDA approval for surgical pain management after addressing prior application issues. The HFSA and ASPC emphasize prevention and early risk management in heart failure care. Zopapogene imadenovec is now the first FDA-approved immunotherapy for recurrent respiratory papillomatosis. The AHA and ACC have updated hypertension guidelines, advocating for earlier intervention to mitigate cardiovascular disease risk.

An audio recap of the top 5 stories in healthcare news from the week of 08/10-08/16.



HCPLive 5 Stories in Under 5: Week of 08/10

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 US Food and Drug Administration approval of 2 generic versions of Venofer (iron sucrose) injection for the treatment of 

, and zopapogene imadenovec-drba (Papzimeos) for adult patients with 

recurrent respiratory papillomatosis (RRP)

, as well as a statement from the Heart Failure Society of America and the American Society for Preventive Cardiology on 

 prevention and a joint guideline from the American Heart Association and the American College of Cardiology suggesting earlier treatment for high blood pressure to reduce 

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 August 10, 2025—let’s jump in!

On August 11, 2025, the FDA approved generic versions of Venofer (iron sucrose) injection for the treatment of iron deficiency anemia in CKD from Viatris Inc and Amphastar Pharmaceuticals.

According to a press release from Viatris, Iron Sucrose Injection, USP, coined by the Company as the first generic version of Venofer Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL. In a separate release, Amphastar said its generic iron sucrose injection met the criteria for bioequivalence and therapeutic equivalence to Venofer and is expected to launch in the third quarter of 2025.

The same day, PharmaTher announced the FDA approval of ketamine (KetaRx) for surgical pain management. The decision follows 2 Complete Response Letters issued in October 22 2024, and April 2024 citing deficiencies in the Abbreviated New Drug Application for ketamine for anesthesia, sedation, pain, mental health, and neurological indications. The deficiencies were classified as minor, with the Agency requesting clarification on drug substance, drug product, manufacturing, and microbiology, but not requesting any new trials.

On August 13, 2025, the Heart Failure Society of America and the American Society for Preventive Cardiology released a joint statement calling for a shift in how clinicians approach heart failure treatment, prioritizing prevention and risk identification rather than accepting it as an inevitable outcome.

 American Journal of Preventive Cardiology

The Continuum of Prevention and Heart Failure in Cardiovascular Medicine

,” presents a framework of potential preventive strategies across the various stages of heart failure, independent of ejection fraction. It also includes secondary prevention strategies in patients with established diseases and tertiary strategies in those with advanced therapies like heart transplants.

On August 14, 2025, the FDA approved Precigen’s zopapogene imadenovec-drba (Papzimeos) for the treatment of adult patients with RRP as the first-of-its-kind non-replicating adenoviral vector-based immunotherapy. The approval was supported by results from a single-arm, open-label trial evaluating zopapogene imadenovec in adult patients with RRP who required ≥ 3 surgeries per year.

On August 14, 2025, the American Heart Association and the American College of Cardiology released a joint guideline suggesting earlier treatment for high blood pressure to reduce cardiovascular disease risk.

The new release replaces the previous 2017 guideline, providing updated or new recommendations for blood pressure management. The collective organizations encourage physical activity, heart-healthy diets, and stress management to reduce the risk of heart attack, stroke, kidney disease, cognitive decline and dementia, and heart failure.

The FDA has approved two generic versions of Venofer for treating iron deficiency anemia in CKD, with Viatris and Amphastar launching their products soon. PharmaTher's ketamine (KetaRx) received FDA approval for surgical pain management after addressing minor application deficiencies. The Heart Failure Society of America and the American Society for Preventive Cardiology emphasize prevention in heart failure management. Precigen's zopapogene imadenovec-drba (Papzimeos) is the first immunotherapy approved for recurrent respiratory papillomatosis. The American Heart Association and American College of Cardiology recommend earlier treatment for high blood pressure to mitigate cardiovascular disease risk.

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