Davy James

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.

Findings from the BATURA Phase IIIb trial demonstrated that Airsupra (albuterol/budesonide) significantly reduced the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma compared to albuterol alone.

In the Phase II PATH-HHT trial, pomalidomide significantly reduced the severity of epistaxis and improved quality of life in patients with hereditary hemorrhagic telangiectasia, offering a potential treatment for the bleeding disorder, which currently lacks FDA-approved therapies.

Ziresovir is a potent, selective, orally bioavailable RSV F protein inhibitor, that has been shown to reduce viral load and the Wang Respiratory Score with a favorable safety profile in hospitalized infant patients with respiratory syncytial virus infection.

Proof-of-concept Phase II ARTEMIS-UC trial shows efficacy of investigational humanized monoclonal antibody tulisokibart in treating inflammatory bowel disease compared with placebo.

Beqvez (fidanacogene elaparvovec), a one-time gene therapy, was approved by the FDA in April 2024 to treat adults with moderate to severe hemophilia B.

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.