The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
New Yamuna Vihar facility to train 40 students annually through diploma-led, hands-on renal care education
CDSCO-approved therapy enters India’s fast-growing post-patent GLP-1 market with fully integrated API, formulation and pen manufacturing
Strategic expansion strengthens CDMO’s support for biotech and pharma innovators across the Asia-Pacific region
API-first, DPI-driven DDRS platform aims to modernize drug and medical device regulation in India
The companies plan to advance multiple solid tumor targets from Regeneron’s antibody portfolio
The study’s multi-technology design is intended to improve reproducibility, strengthen regulatory-grade evidence generation
Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews
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Effective recovery at home begins with well-defined care plans that outline treatment protocols, recovery milestones, and monitoring requirements tailored to individual patient needs
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
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