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 ...
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 ...
The FDA’s Center for Biologics Evaluation and Research (CBER) granted NanoMosaic’s request for an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle technology for multiplex ...
Beginning January 1, 2026, the company's collagen production will operate out of MPM Medical's 100,000 sq. ft. FDA-registered facility in Mesquite, Texas. The expansion includes advanced collagen ...
CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--LumaCyte, a trailblazer in advanced label-free cellular bioanalytical technology and instrumentation, proudly announces the launch of the Laser Force Cytology™ ...
Enables Potential MACI Commercialization Outside of the U.S. CAMBRIDGE, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports ...
On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...
This spring, the Trump administration renewed calls to bring drug manufacturing and production back to American shores, reigniting debate about what it will take to move onshoring from a lofty dream ...
Manufacturing’s future is inextricably linked with robotic advancement. Organizations embracing these transformative ...
(RTTNews) - Vericel Corporation (VCEL) announced that the U.S. FDA has approved commercial manufacturing of MACI at its new state-of-the-art cell therapy facility in Burlington, Massachusetts. The ...
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