Ashley Gallagher, Editor

The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.

The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.

Edaravone and dexborneol sublingual tablets are an innovative first drug to be designed for treatment of stroke and granted this designation.

Previously, the FDA granted fast track designation to ABD-147 (Abdera Therapeutics Inc) for extensive stage small cell lung cancer.

P043 is currently approved for patients 6 years and older with moderate to severe persistent allergic asthma whose disease is inadequately controlled with inhaled corticosteroids.

Pharmacists should be aware of these digital therapeutics, which are often used as an adjunct to medication, to better understand the treatment outcomes.

The application includes data from the Vivacity-MG3 study, demonstrating that individuals who received the drug had superior outcomes compared with the standard of care alone.

In July 2024, the FDA approved the supplemental new drug application for roflumilast cream 0.15% for patients 6 years and older.

With diagnostic tools, oncology pharmacists and other health care providers can help to identify treatments that have the best probability of working for a specific patient.

The guidance, if finalized, would revise considerations about switching studies for proposed interchangeable biosimilars.

Clinical improvements for patients with diabetes seen in a collaboration between the University of North Carolina and Blue Cross and Blue Shield of North Carolina.

Inflammatory conditions such as celiac disease can require care consideration and monitoring to manage iron deficiency

For adults receiving the 15 mg dose, tirzepatide sustained weight loss with an average reduction of 22.9% in body weight compared with 2.1% for the placebo.

The proposed diagnostic agent has a long half-life, enables imaging the next day, and correlates to a longer shelf life in the pharmacy.

This designation follows the drug's rare pediatric disease designation in July 2024.

Investigators compare the impact of semaglutide for preserved ejection fraction and reduced ejection fraction, which both have different causes and responses to treatment.

The Alzheimer disease treatment landscape is evolving with new FDA-approved antibody therapies and advancements in biomarker testing to enable earlier diagnosis and intervention.

Biosimilar etanercept (Sunshine Guojian Pharmaceutical) showed similar therapeutic outcomes compared with etanercept (Enbrel; Amgen) specific to rheumatoid arthritis.

Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.

The drug is currently undergoing a phase 2 clinical trial for patient 12 years or older who are hospitalized with steroid-refractory acute graft-versus-host disease (aGVHD).

The combination is the first and only multi-targeted chemotherapy-free regimen that demonstrated superiority compared with osimertinib for non–small cell lung cancer (NSCLC).

Currently, the drug will be studied in the SKYBRIDGE (NCT05652686) trial, a first-in-human, phase 1/2, open-label, dose-escalation and expansion study.

The biosimilar space continues to grow, with key focuses around retina and oncology, but adoption remains slow in the United States.

The hemostatic gel is plant-based and designed to stop and control bleeding within seconds after applied to wound at the point of care.

The new prices are expected to go into effect for patients with Medicare Part D on January 1, 2026.

The treatment is indicated to improve and maintain visual acuity in individuals with neovascular age-related macular degeneration.

Walgreens will close underperforming stores within the next 3 years, struggling to keep up with front-of-store experiences and regulatory and reimbursement challenges.

The trial evaluated a fixed-dose combination of vibostolimab and pembrolizumab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer.

Palopegteriparatide is a prodrug of parathyroid hormone designed to provide continuous exposure of the hormone over a 24-hour dosing period.