FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...
Pharmaceutical Technology on MSN
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.
The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...
Cell and gene therapy (CGT) has evolved from a niche research pursuit into a central force in biopharmaceutical innovation. By engineering living cells and genetic material to repair or replace faulty ...
Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality ...
HOUSTON, May 12, 2025 /PRNewswire/ -- PackGene Biotech, Inc. announced today six presentations at the American Society of Gene & Cell Therapy (ASGCT) 28 th annual meeting in New Orleans, May 13-17, ...
VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis Therapeutics (“DTx”), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic ...
Catalent is laying off 350 employees in its gene therapy manufacturing division in Baltimore “due to an unexpected shift in demand from a large customer, which made it necessary to reduce our ...
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