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 ...
MPM Medical today announced a major expansion of its U.S. manufacturing capabilities with the acquisition of a full collagen manufacturing platform and the associated FDA 510 (k) clearance for ...
George Tidmarsh and Vinay Prasad have taken leadership roles at CDER and CBER, respectively, impacting FDA's drug and biologics centers. The CNPV pilot program aims to expedite drug approvals by ...
Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
WHITE OAK, Md.--(BUSINESS WIRE)--The Food and Drug Administration’s (FDA) Office of Counterterrorism and Emerging Threats (OCET) has awarded a contract worth over $1.78M to Siemens Government ...
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™ ...
The partnership strengthens INBS' global manufacturing strategy, reducing reliance on a single supplier and building greater resilience into its supply chain. It further broadens capacity, ensures ...
The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed timelines. Sponsors must execute market access, pricing, and post-approval ...
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 ...
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