Therapeutic Areas

Randomized trial finds once daily oral semaglutide 50 mg lowered energy intake, appetite, and food cravings, with improved control of eating and clinically meaningful reductions in body weight after 20 weeks.

Phase IIb trial indicates liraglutide (Novo Nordisk) may reduce cognitive decline associated with Alzheimer disease by protecting against shrinkage in areas of the brain controlling memory, learning, language, and decision-making.

Randomized trial shows Farxiga improved right ventricular pulsatile afterload and myocardial performance during exercise in patients with heart failure with preserved ejection fraction.

Results from an induction trial and maintenance trial show Skyrizi (risankizumab) improved endoscopic and histological secondary outcomes characterized by endoscopic improvement, remission, and histological, endoscopic, and mucosal improvements in patients with moderately to severely active ulcerative colitis.

Antibody-mediated rejection is the primary cause of kidney allograft failure following kidney transplantation.

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.

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 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 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.

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.

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.

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.

Dupixent (dupilumab) was previously granted priority review status as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Leqembi (lecanemab-irmb) was previously granted fast track designation by the FDA for a subcutaneous version of the drug to treat Alzheimer disease in patients with mild cognitive impairment or the mild dementia stage of the disease.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene.