Davy James

Study finds a potential risk of adverse events associated with long-term use of oral corticosteroids in patients with exacerbations of atopic dermatitis.

Paxlovid was the first oral drug approved by the FDA to treat Covid-19 in adults who do not require supplemental oxygen and who have an increased risk of progression to severe disease.

Altuviiio is a first-in-class, high-sustained factor VIII replacement therapy, indicated for routine prophylaxis and on-demand treatment to control bleeding episodes in adults and children with hemophilia.

Study shows patients 80 years and older with atrial fibrillation treated with a lower dose of edoxaban experienced fewer major gastrointestinal bleeding events for each additional ischemic stroke.

Phase III RAISE trial shows superiorty of reteplase over alteplase in improving patients’ functional outcomes without increasing incidence of symptomatic intracranial hemorrhage and death from ischemic stroke within 4.5 hours after symptom onset.

In a Phase I-II trial, CM313 was found to inhibit antibody-dependent cell-mediated cytotoxicity on platelets while achieving long-term efficacy in patients with immune thrombocytopenia.

NF2-related schwannomatosis is a relentlessly progressive tumor predisposition syndrome with no FDA-approved treatments.

Study findings suggest that campaigns starting each year at the beginning of respiratory syncytial virus outbreaks, instead of continuous treatment of newborns throughout the year, may improve the usefulness of the Beyfortus program.

Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial findings indicate that Tivdak (tisotumab vedotin-tftv) may be the preferred second- or third-line treatment option over chemotherapy for patients with recurrent cervical cancer.

Phase III NOTUS trial data show patients with chronic obstructive pulmonary disease and type 2 inflammation administered Dupixent experienced reduced exacerbations and superior lung function compared to placebo.

Patients administered donidalorsen experienced a lower hereditary angioedema (HAE) attack rate, which indicates the potential for prophylactic use in treating HAE.

Phase III trial data shows significant survival benefit with Rybrevant plus Leclaza compared to Tagrisso in the treatment of patients with previously untreated or Tagrisso-pretreated epidermal growth factor receptor–mutated advanced non–small-cell lung cancer.

Phase III trial results show a greater proportion of children aged one to 11 years administered a weight-tiered higher dose of Dupixent achieved a significant improvement across multiple key disease measures for eosinophilic esophagitis compared to placebo.

Phase III SURMOUNT-OSA trial data show positive impact of tirzepatide in patients with moderate-to-severe obstructive sleep apnea and obesity.

Imfinzi (durvalumab; AstraZeneca) combined with chemotherapy led to a statistically significant and clinically meaningful improvement in event-free survival and overall survival compared with neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer.

Omnipod 5 Automated Insulin Delivery System shows improvements in blood glucose outcomes and overall quality of life among patients with type 2 diabetes.

Tremfya (guselkumab) subcutaneous induction therapy shows positive findings for the treatment of adult patients with moderately to severely active Crohn disease.

Columvi with gemcitabine and oxaliplatin (GemOx) achieved statistically significant and clinically meaningful outcomes treating relapsed or refractory diffuse large B-cell lymphoma compared to MabThera/Rituxan plus GemOx.

The FDA approved HyQvia earlier this year as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.

Linvoseltamab was previously granted Priority Review by the FDA for adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

Elrexfio is a BCMA-CD3-targeted bispecific antibody that the FDA granted accelerated approval in August 2023 to treat patients with relapsed or refractory multiple myeloma who were previously administered at least four lines of therapy.

Phase III NextCOVE trial shows Moderna’s next-generation, investigational SARS-CoV-2 vaccine mRNA-1283 achieved the primary efficacy endpoint of non-inferiorty compared with Spikevax in preventing COVID-19.

The Phase III BE MOBILE 1, BE MOBILE 2, and BE MOVING trials show Bimzelx, an IL-17A and IL-17F inhibitor, produced sustained suppression of inflammation over two years and improvements in quality of life among patients with active non-radiographic axial spondyloarthritis and ankylosing spondylitis.

Seladelpar is a first-in-class, oral, selective peroxisome proliferator-activated receptor-delta agonist that has been found to improve markers of liver function and pruritis in patients with primary biliary cholangitis.

GIP receptor and GLP-1 receptor agonist tirzepatide demonstrates superiorty to placebo in MASH resolution in patients with with stage 2 or 3 fibrosis.

Results from the Phase II PICCOLO trial show the promise of Elahere (mirvetuximab soravtansine; AbbVie) in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer.

Enhertu achieved statistically significant and clinically meaningful improvements in progression-free survival compared with standard-of-care chemotherapy among patients with HR-positive, HER2-low metastatic breast cancer.

Results from the Phase III CheckMate -9DW trial show Opdivo plus Yervoy produced a statistically significant and clinically meaningful improvement in overall survival compared with investigator’s choice of sorafenib or lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma.

Tagrisso (osimertinib; AstraZeneca) reduced the risk of disease progression or death by 84% in patients with unresectable, stage III epidermal growth factor receptor-mutated (non-small cell lung cancer with tumors that harbor exon 19 deletions or exon 21 (L858R) mutations.

Results of the Phase III CheckMate -77T, CheckMate -816, and CheckMate -9LA trials show the potential of Opdivo to improve survival among patients with early and advanced stages of lung cancer.