Don Tracy, Associate Editor

FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.

The study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.

The supplemental New Drug Application for brexpiprazole in combination with sertraline is supported by data from three randomized clinical trials that evaluated its safety and efficacy in adult patients with post-traumatic stress disorder.

Expanded indication of Brineura allows for treatment of neuronal ceroid lipofuscinosis type 2 disease in both symptomatic and presymptomatic children.

A single dose of giroctocogene fitelparvovec significantly reduced the mean total annual bleeding rate in patients with moderately severe to severe hemophilia A.

Moving forward, Sage Therapeutics and Biogen intend to cease further clinical development of SAGE-324 for essential tremor.

Results of the PURPOSE 1 trial indicated that treatment with lenacapavir was superior to Descovy and Truvada.

The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors.

The new approval expands Xeomin’s indications to include horizontal forehead lines and lateral canthal lines.

Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.

JAMA study aims to determine whether financial barriers impact access to mental health services.

Novel drug 7MW3711 binds to tumor cell membrane antigens, being internalized and transported to the lysosome, releasing a cytotoxic drug, and inducing tumor cell apoptosis.

Treatment with CT-996 led to a significant placebo-adjusted mean weight loss of 6.1% within four weeks in participants with obesity but without type 2 diabetes.

Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.

The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors.

The agreement enables SOTIO to license multiple fully human bispecific antibodies from Biocytogen's RenLite platform.

DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability.

Clearance of the New Drug Application for ART25.12 allows Artelo to begin a Phase I study for the drug in chemotherapy-induced peripheral neuropathy.

JAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults.

Avexitide has received Breakthrough Therapy Designation by the FDA for post-bariatric hypoglycemia, congenital hyperinsulinism, and more.

According to the Complete Response Letter, the FDA has requested additional information on the manufacturing process and the type 1 diabetes indication for insulin icodec before completing its review.

Acquisition of Yellow Jersey Therapeutics includes access to NM26, a potential treatment for atopic dermatitis.

JAMA study evaluates changes to out-of-pocket costs and utilization of type 2 diabetes medications once patients reach the age of 65 years.

Zoryve is a steroid-free, once-daily treatment shown to offer rapid disease clearance and significant itch reduction for patients with mild to moderate atopic dermatitis.

Approval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.

Acquisition of Morphic is aimed to enhance treatment options for inflammatory bowel disease and expand Lilly's gastroenterology portfolio.

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, discusses results of the Femaseed pivotal trial, Fembloc birth control, and how the outcome of the 2024 United States presidential election could impact women's health.

Results from the Phase III STREAM Stage 2 study show the efficacy and safety of an all-oral bedaquiline-containing regimen for multidrug-resistant pulmonary tuberculosis.

The Vabysmo prefilled syringe is designed to simplify administration for retina specialists, improving the treatment experience for both physicians and patients with wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, offers a description of how Femaseed works to support women who struggle with infertility.