Press Releases
FDA Approves L2 Bio’s Crohn’s Stem Cell Trial with FDAMap Steering the Way
Gaithersburg, MD – May 2025 — In a breakthrough for patients suffering from Crohn’s disease, L2 Bio has received FDA approval to launch a Phase 2 clinical trial investigating its cutting-edge stem cell therapy — a personalized, regenerative approach that could redefine how inflammatory bowel disease is treated in the United States.
FDAMap CEO, Dr. Mukesh Kumar, to Speak on "Global Drug Development Strategies in the New Political Environment" at IAICC 2025 Convention
Gaithersburg, MD – April 2025 – FDAMap is pleased to announce that our CEO, Dr. Mukesh Kumar, has been invited to deliver a presentation on “Global Drug Development Strategies in the New Political Environment” at the upcoming IAICC 2025 Convention, scheduled for May 2–3 in Washington, D.C.
FDA Approves GIOSTAR's Landmark Clinical Trial
For Autologous Stem Cell Treatment with Crucial Support from FDAMap.
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.
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.
Akan Biosciences, Inc receives a MOVE Grant from the Montgomery County Government
Montgomery County, Md. May 19, 2022 The Montgomery County Government has approved a MOVE Grant for the biotech company Akan Biosciences, lnc (Akan) to support their office space in the County…
FDA Accepted Akan Bio's IND Application for Osteoarthritis
GERMANTOWN, Md., Feb. 16, 2021, Akan Biosciences, LLC (Akan), a Maryland-based, clinical-stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) had accepted the Investigational New Drug Application (lND) for StroMelTM, its lead candidate for the treatment of Osteoarthritis of Knee. The active IND enables Akan to start clinical trials.
