Vericel Announces FDA Approval of New State-of-the-Art Advanced Therapy Manufacturing Facility

Company Achieves Significant Regulatory and Operational Milestone Substantially Increases Manufacturing Capacity to Support Long-Term Growth ...
FiercePharma

Ori's cell and gene platform wins key FDA advanced manufacturing designation

Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...
JD Supra

FDA Launches PreCheck and Advanced Manufacturing Technologies Designation Programs to Strengthen U.S. Drug Manufacturing

The U.S. Food and Drug Administration (FDA) recently launched two initiatives to help onshore U.S. pharmaceutical manufacturing: the FDA PreCheck Program to streamline review of pharmaceutical ...
Morningstar

Ori Biotech’s IRO® Platform Receives FDA Advanced Manufacturing Technology (AMT) Designation

Launched in 2024, IRO is one of the first technologies to receive AMT designation, validating the platform as a leading, next-generation solution for overcoming the critical challenges in cell and ...
Morningstar

MPM Medical Expands U.S. Manufacturing Capabilities, Acquires FDA 510(k) for Surgical and Advanced Wound Care Collagen

New production capacity strengthens MPM Medical's position as a leading U.S. manufacturer and follows the company's recent launch of collagen at-home wound care kits MESQUITE, Texas, Dec. 16, 2025 ...