Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after ...

Lumacyte CEO on how real-time insight is driving down manufacturing failures and opening doors for more patients.

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...

The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...

Kincell Bio, a leading contract development and manufacturing organization (CDMO) in cell therapy, today announced the ...

The first half of 2025 has been a notable one for Cellares. The cell therapy manufacturer operates its first commercial-scale Integrated Development and Manufacturing Organization Smart Factory in ...

- Joint venture will aim to develop a cell therapy manufacturing platform through robotics and will offer access to startups and academic institutions - In the pharmaceutical industry, the ...

The AMT designation gives Cellares’ clients using the Cell Shuttle priority review with the FDA leading to accelerated regulatory filings SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the ...

Cell therapy developer Arcellx contends its lead program could be a safer alternative to currently available CAR T-treatments for multiple myeloma, noting that its previously reported preliminary data ...

Wang also acknowledges emerging platforms such as CAR NK cells and in vivo CAR T technologies but notes these remain ...