FDA increases manufacturing flexibility for cell and gene therapies

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

Certain Stem Cell Products Require FDA Premarket Approval

On September 27, 2024, in USA v. California Stem Cell Treatment Center, Inc., the US Court of Appeals for the Ninth Circuit issued a decision agreeing with the US Food and Drug Administration (FDA) ...
FiercePharma

Cellares' cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA

A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s Cellares has passed another major production milestone. Cellares’ automated ...
PharmiWeb

CellVoyant launches new online predictive cell analytics platform to fast-track drug development

CellVoyant, an AI-first biotech based in Bristol UK,  today launches FateView™, the first online predictive cell analytics platform designed to help cell-based therapeutic drug developers reduce costs ...
JD Supra

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding ...