Tag: IND
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NanoMosaic Earns FDA AMT Designation for Advanced Gene Therapy Analytics
NanoMosaic Secures FDA AMT Designation for Advanced Gene Therapy Analytics NanoMosaic has been awarded the FDA’s Advanced Manufacturing Technology (AMT) designation, a status reserved for platforms that demonstrably improve efficiency, product quality, and regulatory readiness in complex manufacturing environments. This recognition underscores NanoMosaic’s commitment to advancing gene therapy analytics and supporting developers navigating the regulatory…
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NanoMosaic Earns FDA Advanced Manufacturing Technology Designation to Accelerate Gene Therapy Analytics
Overview: A Milestone for Gene Therapy Analytics NanoMosaic has secured the U.S. Food and Drug Administration’s (FDA) Advanced Manufacturing Technology (AMT) designation for its cutting-edge analytics platform. This recognition underscores the company’s ability to streamline complex gene therapy workflows, enhance product quality, and improve FDA engagement for developers and manufacturers pursuing advanced therapies. As gene…
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D3 Bio Secures FDA Clearance for Two INDs, Jumpstarting Phase 1 and Phase 2 Trials
FDA Clears Two INDs for D3 Bio, Launching Key Clinical Trials Shanghai-based D3 Bio, a clinical-stage biotechnology company focused on transformative oncology therapies, has announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications. The approvals enable a Phase 1 clinical trial for D3S-003 and a Phase 2…
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D3 Bio Sees FDA IND Clearance for D3S‑003 and Elisrasib Combination Study
FDA Clearance Accelerates D3 Bio’s Oncology Programs The U.S. Food and Drug Administration (FDA) has granted clearance for two Investigational New Drug (IND) applications from D3 Bio, a global clinical‑stage biotechnology company focused on transforming cancer therapy. The approvals authorize a Phase 1 trial of D3S‑003 and a Phase 2 study examining Elisrasib (D3S‑001) in…
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IND vs SIN Live: India Draws 1-1 with Singapore in Asian Cup Qualifiers – Match Recap
India vs Singapore Live: A dramatic 1-1 draw in Singapore’s National Stadium In a high-stakes Asia Cup qualifying clash, India battled to a 1-1 draw with Singapore at the National Stadium in Singapore. The game featured a red card, a late equaliser, and a testament to the brutal realities of qualification football where every point…

