PharmTech

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

The draft guidance allows flexibility in using advanced technologies for drug product integrity and batch uniformity, potentially reducing reject rates. Concerns were raised about the definition of ...
PharmTech

Considering the Promises of Point-of-Care Manufacturing

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is ...
Pharm Exec

WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy

Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer. WuXi Advanced Therapies announced that it has officially received approval from the FDA to ...
Pharm Exec

Eli Lilly, Johnson & Johnson Invest in New Drug Manufacturing Facilities

New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines. Eli Lilly and Johnson & Johnson (J&J) have both announced major investments in advanced drug ...

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

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 ...
KXAN

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 ...