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 ...

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 ...

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

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 ...

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™ ...

This article explores current OSD development and manufacturing trends from a CDMO perspective, including the evolution of ...

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 ...

FDA expanded zongertinib’s accelerated approval to treatment-naïve HER2-mutant advanced NSCLC, contingent on mutation ...

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety ...