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 facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated
The new service delivers end-to-end support, managing every stage of an epigenomics project
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
Nine-month revenue grew 17.5% to Rs 76,277 lakh, EBITDA climbed to Rs 15,981 lakh, and net profit reached Rs 8,200 lakh
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
Profitability metrics showed a sharper upward trend. Gross margin expanded 280 basis points to 61.2%
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