CLINICAL ROLE -
Gillian McGovern is an associate editor at Pharmacy Times®. She graduated from Rowan University in 2023 with a BA in Writing Arts and concentrations in Publishing & Writing for the Public, Technical & Professional Writing, and Creative Writing.
Nuvalent Initiates Phase 3 ALKAZAR Trial of Neladalkib in NSCLC
Neladalkib enters phase 3 trials, targeting advanced ALK-positive NSCLC, promising improved outcomes for TKI-naïve patients with brain metastases.
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FDA Issues Complete Response Letter for Glofit-GemOx in R/R DLBCL
The CRL states that the STARGLO data do not provide sufficient evidence to support the second-line indication in the US patient population.
Follow-Up Study Confirms Omlyclo Biosimilarity to Xolair in Treatment of CSU
The biosimilar showed similar efficacy, pharmacokinetics, pharmacodynamics, safety, quality of life, and immunogenicity in patients with chronic spontaneous urticaria (CSU).
Study: Recommendations From Health Care Professionals Improve Immunization Rates Among Patients With CKD
Patients with chronic kidney disease (CKD) were more likely to get vaccinated for influenza and pneumococcal following a health care provider’s recommendation.
FDA Approves Expanded Labeling of Farapulse PFA System for Persistent Atrial Fibrillation
The expanded instructions for use labeling expand on the Farawave and Farawave Nav Pulsed Field Ablation (PFA) catheters.
Expanding Access and Expertise: How Psychiatric Pharmacists Can Bridge Behavioral Health Gaps
BCPPs can address behavioral health workforce shortages and advocate for expanded access and reimbursement amid evolving legislation and treatment landscapes.
Riliprubart Receives FDA Orphan Drug Designation for AMR in Solid Organ Transplantation
This designation is significant because there are no FDA-approved treatments for transplant recipients with or preventing antibody-mediated rejection (AMR).
Board-Certified Psychiatric Pharmacists Have a Significant Role, Experts Say
These health care professionals are crucial to optimizing safety in medication therapy, addressing policy barriers, and the collaboration with others in the field.
Hematologic Highlights from ASCO 2025: CARTITUDE-1 and STARGLO
The long-term outcomes from the CARTITUDE-1 trial in multiple myeloma and durable complete response data from the STARGLO trial in diffuse large B-cell lymphoma can be significant for these disease states.
Steroid Use During ICI Treatment Lessens Effectiveness in Patients With NSCLC
Steroids hindered the shrinkage of tumors in patients with non-small cell lung cancer (NSCLC) receiving immune checkpoint inhibitor (ICI) therapy.
Infliximab Biosimilar Initiation Has Increased in Pediatric IBD, Study Finds
The study found biosimilar initiation rose to nearly 42% from 2016 to 2023.
Sebetralstat Becomes First and Only FDA-Approved Oral, On-Demand Treatment for HAE
Sebetralstat becomes the first FDA-approved oral treatment for hereditary angioedema (HAE), offering rapid relief for patients experiencing acute attacks.
Efepoetin Alfa Noninferior to Mircera When Correcting Anemia, Maintaining Hemoglobin in CKD
Patients with chronic kidney disease (CKD) receiving efepoetin alfa demonstrated a response rate of about 75.6%.
Study: High Long-Term Exposure to Fine Particulate Air Pollution Is Associated With Diffuse Myocardial Fibrosis
The data emphasize the idea that there are no safe exposure limits as well as the need for guidelines.
Real-World Data Show Similar Clinical Outcomes in Patients Receiving Biosimilars Following Switch From Reference Product
Real-world data show that patients switching from Humira to biosimilars Hadlima and Hyrimoz achieve similar outcomes without hospitalization.
FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia
The letter cited deficiencies previously identified at a third-party manufacturing vendor unrelated to oxylanthanum carbonate (OLC).
Pharmacists Have a Crucial Role Helping Patients With ATTR-CM Navigate Treatment With Tafamidis
Pharmacists can help oversee the treatment process to ensure patients with transthyretin amyloid cardiomyopathy (ATTR-CM) are adhering to tafamidis.
FDA Approves Amyvid Injection Updated Label to Support Diagnosis of Alzheimer Disease
Amyvid is used for brain imaging to estimate amyloid plaque density in patients with cognitive impairment undergoing evaluation for Alzheimer disease.
Real-World Data Suggest Cannabis Use is Associated With Major Adverse Cardiovascular Events
Health care professionals are encouraged to educate patients on potential cannabis-related risks to cardiovascular health.
Belimumab Autoinjector Receives FDA Approval for Children With Active Lupus Nephritis
Compared with prior intravenous formulations, the autoinjector is a more accessible administration method for children and their caregivers.
Study Confirms Interchangeability of Hulio, Biosimilar of Humira, in Severe Chronic Plaque Psoriasis
Hulio shows comparable efficacy and safety to Humira in treating chronic plaque psoriasis, supporting its FDA interchangeability status.
Lorundrostat Shows Clinically Meaningful Outcomes in Patients With CKD and Hypertension
Lorundrostat reduces blood pressure and urine albumin-to-creatinine ratio in patients with chronic kidney disease (CKD) and hypertension.
Nitisinone Becomes First and Only FDA-Approved Treatment for HGA in Adults With AKU
Its approval was based on data from a 3-year trial that enrolled patients with alkaptonuria.
Multi-Phenotype Approach Highlights Increased Power of cPCA When Identifying CKD-Related Loci
The authors note that the combinatorial principal component analysis (cPCA) may be effective in other complex diseases outside of chronic kidney disease (CKD).
FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA
The subcutaneous infusion is indicated for pediatric patients aged 6 to 17 years who weigh less than 60 kg.
Beyond Dispensing: How Pharmacists and Technicians Can Expand Services to Meet Patient Needs
Pharmacists and pharmacy technicians are key to offering more accessible and efficient care.
ASCO 2025: Ribociclib With NSAI in HR+/HER– Breast Cancer Improves iDFS, Yields Substantial Work Productivity Gains
Ribociclib in combination with a nonsteroidal aromatase inhibitor (NSAI) improved invasive disease-free survival (iDFS) while allowing for better quality of life in hormone receptor-positive (HR+)/human epidermal growth receptor 2-negative (HER2−) early breast cancer.
Finerenone and Empagliflozin Outperform Either Treatment Alone in Patients With CKD
Patients with chronic kidney disease (CKD) and type 2 diabetes receiving both treatments had greater reductions in urinary albumin-to-creatinine ratio.
Understanding Biologics and Biosimilars Amid an Evolving Treatment Landscape
Biologics and biosimilars have a major role in modern medicine because of their clinical benefits and economic impact on patient care.
Addressing Pharmacy Deserts and Expanding the Pharmaceutical Workforce
Innovative strategies are essential to recruit pharmacy students and transform practices, ensuring equitable access to pharmacy services in underserved areas.