This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development
Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
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