News | February 05, 2026
AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
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 facility will bring 850 high-value jobs to the region, including engineers, scientists, operations personnel, and lab technicians
CSPC will receive an upfront $1.2 billion from AstraZeneca for access to eight programmes, AI molecular design capabilities, and the LiquidGel platform
HD causes cognitive, behavioral, and physical challenges, including involuntary movements known as HD chorea, which can disrupt daily life
The successive PLI disbursements validate our disciplined execution and sustained commitment to strengthening India’s domestic pharmaceutical manufacturing capabilities
In the SHORE phase 3 study, amlitelimab, used in combination with topical therapies, met all primary and key secondary endpoints at Week 24
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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