The validations confirm the completion of the applications and commence the scientific review process
LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
CuraTeQ Biologics is on track for filing a second oncology biosimilar
Singlera and Pure Medical will team up with local universities, hospital networks, and national healthcare systems across Western Europe for research studies
The Signals Xynthetica solution brings AI-driven in-silico generation, predictive modeling, and experimental validation into a single, governed environment
Prolia is a prescription medicine used to treat osteoporosis in women
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years
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