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Expert Insights on Clinical Research and Regulatory Compliance
FDAMap Clinical
Expert Insights on Clinical Research and Regulatory Compliance
FDA Approves GIOSTAR's Landmark Clinical Trial for Autologous Stem Cell Treatment with Crucial Support from FDAMap. Read More>>
Gaithersburg, MD – November 2024 – FDAMap proudly congratulates GIOSTAR (Global Institute of Stem Cell Treatment and Research) on receiving FDA approval for their first clinical trial in the U.S. for an autologous stem cell treatment targeting diabetes. This groundbreaking development represents a significant advancement in diabetes research and reflects GIOSTAR’s commitment to innovative and transformative healthcare solutions.
FDA Accepts NDA for LipidRescue™ with PDUFA Date Set for June 2025 – Regulatory Milestone Achieved with FDAMap Clinical’s Expert Guidance. Read More>>
FDAMap Clinical is thrilled to announce the successful submission of ResQ Pharma’s NDA for LipidRescue™, a critical care treatment for Local Anesthetic Systemic Toxicity (LAST). The FDA has set a PDUFA date of June 2, 2025, for this application.
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