Drug Approval | January 31, 2024
Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America
Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer
Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
Comprehensive clinical development programs being initiated for each investigational candidate
Innovent will supply sintilimab for the collaborated clinical trial
Elpiscience will receive up to US $37 million, including the upfront payment and license option fees
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
The commissioning of the facility represents the culmination of a £45m investment to address rapidly growing demand for ADC manufacturing, supported by a £2.4m Scottish Enterprise grant
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Subscribe To Our Newsletter & Stay Updated
