News

BioSpace6d
Sarepta Wins FDA’s Platform Technology Designation, Marking ‘Critical Shift’ in Gene Therapy Development
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug ...
tcmc to Showcase Asia's Leading Cell & Gene Therapy CDMO Capabilities at BIO International Convention
Taiwan Cell Manufacturing Company (tcmc), a leading Contract Development and Manufacturing Organization (CDMO) in cell and ...
BioPharma Dive7d
FDA to use new review tool on Sarepta’s gene therapy work
The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene ...
BioPharma Dive5d
FDA meeting gives window into gene therapy field’s angst
Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...
Cellex Cell Professionals: A Decade of Cell & Gene Therapy Manufacturing and Major GMP Facility Expansion: Cellex's Track Record of Scalable Excellence
Facility expansions and over 5,800 CGT/ATMP batches manufactured underscore Cellex's strength as a trusted full-service CDMO in Europe. COLOGNE, Germany, June 10, 2025 /PRNewswire/ -- Cellex ...
TMCnet2d
ScaleReady Announces a G-Rex® Grant has been awarded to Immuneel Therapeutics
ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that Immuneel Therapeutics has been awarded a $150,000 G-Rex® Grant to support ...
No More Transplants? New Gene Therapy Targets Blood Stem Cells Directly
Researchers have identified an early postnatal window that allows gene transfer to circulating blood stem cells, advancing ...
Sickle cell gene therapy offers hope to N.J. teen
New gene therapy improves the life of 18-year-old with Sickle Cell Disease which affects 5,000 New Jersey residents living ...