FDA launches PreCheck program to bring drug manufacturing back to US
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
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
This achievement validates global demand and catapults Wanbury into high-growth acceleration
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 Poultry Healthcare Division delivered a strong performance, posting 32% revenue growth in Q3 FY26 and 17% growth over the nine-month period
Profitability metrics showed a sharper upward trend. Gross margin expanded 280 basis points to 61.2%
The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave
CSPC will receive an upfront $1.2 billion from AstraZeneca for access to eight programmes, AI molecular design capabilities, and the LiquidGel platform
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