Approval was based on results from the Phase IIIb TRAILBLAZER-ALZ 6 trial, which showed that Kisunla achieved comparable efficacy in amyloid plaque and P-tau217 reduction while lowering the risk of amyloid-related imaging abnormalities with edema or effusion in patients with early Alzheimer disease.
The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.
The drug is currently in Phase 1 clinical trials for gastric cancer treatments.
Ohtuvayre will become part of Merck’s cardio-pulmonary pipeline.
Approval was based on results from the DOORwaY90 trial, which demonstrated a 98.5% overall response rate and 100% local tumor control in patients treated with the SIR-Spheres Y-90 resin microspheres for unresectable hepatocellular carcinoma.
The supplemental New Drug Application is supported by Phase III data, which showed Caplyta significantly prolonged time to relapse compared to placebo and reduced the risk of relapse by 63% in patients with schizophrenia.
While the growing oncology pipeline offers tremendous potential, the path from clinical development through to commercial launch and patient administration is complex and lined with challenges that can impact product success and access.
Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older.
Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, outlines how the company is working to ease care transitions, support community oncologists, and reduce overwhelm in cancer treatment delivery.
The organization says that millions of Americans will lose access to mental health care.
The delivery method showed promise in preventing the illness.
Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, shares how the company is supporting cancer care teams through timely education, community-based trials, and tools to manage complex treatment transitions.
The Phase II THULITE trial will analyze the safety and efficacy of BI 1815368, an investigational oral therapy designed to reduce fluid leakage in the retina and ease the treatment burden for patients with diabetic macular edema.
Accelerated approval was based on results from the Phase I/II LINKER-MM1 trial, which showed a 70% objective response rate in patients with relapsed or refractory multiple myeloma treated with Lynozyfic.
Results from the Phase III ZENITH trial show that patients treated with Winrevair (sotatercept-csrk) for pulmonary arterial hypertension experienced a 76% reduction in the composite risk of death, lung transplant, and ≥24-hour hospitalization.
The AI company’s tech will be integrated with Microsoft Azure’s infrastructure.
The fundraising event will debut in Nashville this August.
The new platform integrates PCR-based diagnostic data with statistical modeling and AI to provide real-time visibility into infectious disease trends at local and global levels.
Updated label allows Neuraceq to be used in selecting patients for amyloid-targeting therapies and includes the use of quantitative PET imaging metrics to support diagnosis and monitor disease progression in Alzheimer’s care.
Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine, discusses the importance of collaboration across the healthcare community to develop inclusive and effective AI solutions that enhance decision-making and patient outcomes in oncology.
Results from the Phase III VEGA-3 trial show that a significantly higher number of patients with presbyopia who received MR-141 achieved a ≥3-line gain in binocular near visual acuity without compromising distance vision compared to placebo.
The transaction, finalized following regulatory clearance, includes two FDA-approved rare tumor therapies: Ogsiveo for desmoid tumors and Gomekli for symptomatic plexiform neurofibromas.
Results from the Phase III Vivacity-MG3 trial show that Imaavy provides more consistent disease control than other approved FcRn blockers in adults with generalized myasthenia gravis.
The football player is speaking out about his experience living with and treating OAB.
Biljana Naumovic, US President, oncology, solid tumor, Johnson & Johnson Innovative Medicine discusses key takeaways from the Oncology Care Index and how they are shaping the company’s approach to clinical research, community partnerships, and continuity of care.
The supplemental premarket approval application is supported by Phase III data, which showed significant improvements in neck appearance in patients treated with Skinvive.
Gamifant marks the first-ever FDA-approved treatment for both adult and pediatric patients with hemophagocytic lymphohistiocytosis macrophage activation syndrome in the context of known or suspected Still's disease.
Under terms of the deal, AbbVie will acquire Capstan’s lead asset, CPTX2309—an in vivo anti-CD19 CAR T-cell therapy in Phase I development for B cell-mediated autoimmune diseases.
Customers will be able to access prescription services through the NovoCare Pharmacy.
The actor suffers from the ear condition after an accident on set during the filming of Star Trek.
