Don Tracy, Associate Editor

Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.

Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5 years of treatment.

Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.

Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.

Results of the INTEGUMENT-OLE study found that the roflumilast cream not only maintained but improved its efficacy over time treating children from two to five years of age with mild to moderate atopic dermatitis.

A new National Institutes of Health grant will advance research into the role of the serotonin 5-HT2A receptor in mitigating methamphetamine use.

Topline results from the Phase III V-MONO study of Leqvio found that twice-yearly Leqvio achieved clinically LDL-C lowering compared to both placebo and ezetimibe.

The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity.

Shorespan-007 is expected to enroll approximately 300 patients with essential thrombocythemia and will compare bomedemstat to hydroxyurea, the current standard of care.

Expanded indication makes Omnipod the first automated insulin delivery system to be approved for the management of both type 1 and type 2 diabetes.

Results from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52 weeks.

The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects in the knee.

64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.

Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.

Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.

Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.

Breakthrough therapy designation for GSK5764227 based on preliminary data from the ongoing ARTEMIS-001 Phase I trial, which showed the novel therapy’s promise treating patients with relapsed or refractory extensive-stage small-cell lung cancer.

The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.

Approval marks the first multitargeted regimen to surpass Tagrisso in efficacy in the first-line treatment of advanced non-small cell lung cancer, according to Johnson & Johnson.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, chief medical officer, IMF, offers a glimpse at multiple initiatives that the IMF is working towards to improve myeloma treatment globally.

Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.

The combination treatment involves administering Imfinzi with neoadjuvant chemotherapy for non-small cell lung cancer before surgery and as monotherapy post-surgery.

Surviving a long road, novel next-generation treatment offers hope for major depressive disorder.

A breakthrough for biomarker-altered breast cancer—but broader challenges remain.

Cresilon works to stop life-threatening bleeding in seconds, offering a valuable tool for military, emergency medical services, and healthcare professionals.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, explains the goals of the inaugural Iceland Cycling Expedition.

Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus.

UGN-102 has the potential to be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, UroGen says.

Approval of Nemluvio was based on positive results from the Phase III OLYMIA trials, which demonstrated significant itch reductions.