The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
The company’s total income jumped 31% year-on-year to Rs 125.5 crore
The base Gland business posted ?11,790 million in revenue, up 16% YoY
The Tanuku facility will focus on the production of key therapeutic APIs, including Anti-Tussive, Anti-Coagulant (Blood Thinner), Anaesthetic, and Antidepressant molecules
The newly certified kits are designed for early detection and large-scale screening programs
The new functionality complements Parse’s existing Evercode immune products
The approval expands the drug’s existing COPD indication, making it the only single-inhaler triple therapy (SITT) available for both respiratory conditions in China
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