Davy James

Results from the Phase III CARTITUDE-4 trial show Carvykti (ciltacabtagene autoleucel) is the first and only cell therapy to show an overall survival benefit compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma.

Phase III REGENCY trial results highlight potential of Gazyva/Gazyvaro (obinutuzumab) to improve outcomes in lupus nephritis patients, reducing progression to end-stage kidney disease.

Bristol Myers Squibb and 2seventy bio have ceased enrollment in the Phase III KarMMa-9 trial, stating that advances in induction therapies for newly diagnosed multiple myeloma have reduced the eligible patient population for the trial.

Ebglyss was approved by the FDA earlier this month to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older who weigh at least 88 lbs.

Phase III KEYNOTE-522 trial data show Keytruda (pembrolizumab) plus chemotherapy lowered the risk of death by 34% compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

Niktimvo (axatilimab) gained FDA approval in August 2024 to treat graft-versus-host-disease in patients who did not achieve a response to at least two prior lines of systemic therapy.

Cabozantinib (Cabometyx, Cometriq) shows potential as a new standard of care for patients with advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors in Phase III CABINET trial.

Results from the the Phase III NIAGARA trial show Imfinzi (durvalumab) is the first immunotherapy regimen to significantly extend overall survival in patients with muscle-invasive bladder cancer.

Kesimpta (ofatumumab) demonstrates efficacy lowering disability progression and disease activity in different populations of patients with relapsing multiple sclerosis.

DESTINY-Breast12 trial results show Enhertu (trastuzumab deruxtecan) produced substantial overall and intracranial clinical activity in patients with HER2-positive metastatic breast cancer and brain metastases, supporting its potential use as a second-line treatment.

Data from the Phase III HIMALAYA trial found the combination of Imfinzi plus Imjudo reduced the risk of death by 24% compared to sorafenib in patients with unresectable hepatocellular carcinoma.

Ten-year results from the Phase III CheckMate -067 trial reveal that the combination of Opdivo and Yervoy significantly improves overall survival in patients with advanced melanoma, offering the longest-reported survival data in this population.

Phase III ADRIATIC trial results show that Imfinzi (durvalumab) significantly improves overall survival and progression-free survival compared to placebo in patients with limited-stage small-cell lung cancer.

Potential first-in-class B7-H3 directed antibody drug conjugate ifinatamab deruxtecan shows potential to improve outcomes for patients living with difficult-to-treat form of lung cancer.

Study finds nearly 75% of patients with heterozygous familial hypercholesterolemia achieved a ≥50% drop in serum LDL-C concentration from baseline to about 12 months of therapy with a PCSK9 inhibitor.

Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.

Edoxaban monotherapy lowered the risk of adverse outcomes, including death from any cause, myocardial infarction, stroke, and systemic embolism at 12 months compared to the dual antithrombotic therapy approach in patients with atrial fibrillation and stable coronary artery disease.

The first-in-class, investigational RNA interference drug plozasiran was found to lower triglyceride levels and incidence of pancreatitis compared to placebo in patients with persistent chylomicronemia, including patients with familial chylomicronemia syndrome.

Crinecerfont was granted previously granted FDA Priority Review designation to treat children, adolescents, and adults with classic congenital adrenal hyperplasia.

Cohort study finds a superior tolerability profile with darolutamide compared to other androgen receptor inhibitors, which investigators said indicates an efficacy advantage in the treatment of nonmetastatic castration-resistant prostate cancer.

Investigators conclude that policies seeking to lower rates of diabetes may also contribute to the goal of ending tuberculosis.

Elinzanetant was found to significantly lower the frequency and severity of moderate to severe vasomotor symptoms with statistically significant improvements in sleep disturbances and menopause-related quality of life.

Mild or moderate acute kidney injury has been linked to increased morbidity and mortality, with a greater risk of chronic kidney disease in patients who undergo cardiac surgery with cardiopulmonary bypass.

A higher percentage of patients with advanced clear-cell renal cell carcinoma administered Welireg were alive and without disease progression compared to everolimus at 12 and 18 months.

Phase III REST-ON trial data show higher rates of weight loss in patients administered Lumryz to treat both narcolepsy type 1 (with cataplexy) and narcolepsy type 2 (without cataplexy) compared with placebo.

Patients administered tirzepatide (Zepbound and Mounjaro; Eli Lilly) also achieved sustained weight loss in Phase III trial, with individuals administered the 15 mg dose showing a 22.9% average reduction in body weight compared with 2.1% among those receiving placebo.

Cohort study shows Xtandi (enzalutamide) achieved statistically significant improvements in overall survival vs. abiraterone acetate in the treatment of metastatic castration-resistant prostate cancer.

Induction therapy comprised of Sarclisa (isatuximab-irfc; Sanofi) plus lenalidomide, bortezomib, and dexamethasone significantly improved progression-free survival from first randomization in transplant-eligible patients with newly diagnosed multiple myeloma.

Results show nipocalimab could address the high unmet need of patients with severe hemolytic disease of the fetus and newborn, which is a life-threatening and rare condition with no other therapies currently in clinical development.

Study shows efficacy of olanzapine in improving complete response rates and chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens comprised of oxaliplatin, carboplatin, or irinotecan.