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Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.

Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.

The company includes the technology in drug development, improving efficiency, and other areas.

Sun Life U.S. teamed up with several other Florida-based companies to provide needed assistance in areas impacted by the recent storms.

Partnership is expected to develop radioligand therapies based on lead-212 alpha-emitting isotopes, which offer the opportunity to destroy cancer cells with minimal damage to healthy tissue.

Vyalev is the first and only FDA-approved subcutaneous 24-hour infusion of a levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson disease.

The organization hopes to collect data to provide better education around Thrombosis.

Dr. Sandra Lee is joining the educational program, which originally launched last year.

Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.

Results from the Phase III Vivid-1 trial found that more Crohn disease patients treated with mirikizumab achieved histologic response at week 52 compared to ustekinumab.

As part of the collaboration, Exelixis and Merck will evaluate zanzalintinib in combination with Keytruda for head and neck cancer.

Expanded indication of Bimzelx offers a prefilled syringe with a single 2 mL subcutaneous injection, improving upon the previous regimen of two 1 mL injections.

S-HiCon can reportedly achieve stable liquid formulation for over 200 mg/mL subcutaneous administration.

MedHub has been expanded to work with a wider variety of insurance plans.

Acquisition of Longboard grants Lundbeck access to bexicaserin, 5-HT2C receptor agonist that has demonstrated promise in treating seizures associated with rare developmental epileptic encephalopathies.

Hympavzi is the first anti-tissue factor pathway inhibitor therapy to be approved in the United States for routine prophylaxis of bleeding in patients with hemophilia A or B without inhibitors.

Roaldi previously served as chief growth officer for UnitedHealthcare Community & State.

JAMA study finds that redispensing oral anticancer drugs reduces approximately two-thirds of medication waste as healthcare stakeholders seek more sustainable practices.

The campaign comes during a time when the nation is facing a blood shortage.

Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.

The two companies will continue to collaborate on weight loss medications.

The latest news for pharma industry insiders.

The program will now cover 15 gene and cell therapies.

Data from the Phase III AReSVi-006 clinical trial found that Arexvy offered a cumulative efficacy of 62.9% against lower respiratory tract disease caused by respiratory syncytial virus.

Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA without emergency use authorization.

A new study found that among 2,200 patients with irritable bowel diseases, 63% encountered financial barriers that led to missed doses of medication.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways that digital passports can help ensure patients receive the correct medication.

Sustainable diet habits include behaviors like sticking to a diet plan and avoiding alcohol.

Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.