Laguna Diagnostics secures FDA breakthrough tag for mRNA test in psychiatric diagnosis
The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder
The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder
They also differentiated the innovator biologic Semaglutide molecule from newer synthetic or chemical generic versions entering the market
The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy
They stressed that while the drug is clinically proven to support weight and blood sugar control, it must be prescribed only after careful patient evaluation and used under strict medical supervision.
KeyCi’s dermatologically tested lineup emphasizes clean formulations—vegan, cruelty-free, alcohol-free, and paraben-free—while being backed by pharmaceutical-grade research and FDA approval
The trial’s primary goal is to evaluate vipoglanstat’s effect on endometriosis-related pain during non-menstrual days
The biotechnology company will tap into Catalent’s expertise in induced pluripotent stem cells and advanced cell-therapy manufacturing
Germany will be the first launch market
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
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