FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Moderna’s mNEXSPIKE generates strong immune response against LP.8.1 variant in humans

Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains

European Commission approves Lilly’s Kisunla for treatment of early Alzheimer’s patients

FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy

Agency initiates safety label change and notifies physicians of possible link

Teva unveils promising SOLARIS resultsfor Olanzapine LAI

No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks

Real-world data shows strong symptom relief and patient satisfaction with Teva’s Austedo XR

Datavant partners with Indegene to power clinical trial recruitment

Collaboration matches more eligible patients, including those with rare and complex diseases, to appropriate clinical trials

Roche secures CE mark for Accu-Chek SmartGuide CGM with mySugr app integration

This predictive technology empowers people with diabetes to take preventive action before complications arise

CuraTeQ Biologics completes Phase 3 clinical study for Denosumab biosimilar

Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo