ENHERTU approved in China as first HER2-targeted ADC for early breast cancer
The decision is based on the phase 3 DESTINY-Breast11 trial
The decision is based on the phase 3 DESTINY-Breast11 trial
The inspection is now closed, and no regulatory action has been recommended
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
IntraSight Plus enables confident decision-making and better patient care,” Philips said, emphasizing efficiency, simplicity, and precision
Beyond clinical trials, real-world evidence is adding weight to AbbVie’s claims
High-level results from the Phase III OBERON and TITANIA trials revealed that the first-in-class monoclonal antibody reduced the annual rate of moderate-to-severe COPD exacerbations compared with placebo
TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances
The Cambridge hub is designed to expand Zealand Pharma’s global research capabilities
The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency
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