News | February 04, 2026
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
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
As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects
The new service delivers end-to-end support, managing every stage of an epigenomics project
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
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
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