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.
"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...
With the FDA expecting to approve 10–20 Cell and Gene Therapies (CGTs) annually by 2025, it is evident that the field will continue to hold immense commercial and medical opportunities. To harness ...
Gene therapy is a revolutionary field in modern medicine, offering transformative potential to treat and potentially cure a wide range of genetic and acquired diseases. By addressing the root cause of ...
Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing ...
Polyplus, part of Sartorius, agreed to collaborate with MarkHerz, a Korean cell and gene therapy (CGT) CDMO, to develop new CGT efficiency standards focused on decreasing cost and increasing quality ...
AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...
This story is part of a series on the current progression in Regenerative Medicine. In 1999, I defined regenerative medicine as the collection of interventions that restore tissues and organs damaged ...
HOLLISTER, Calif., Oct. 13, 2022 (GLOBE NEWSWIRE) -- Alpha Teknova, Inc. (TKNO) (“Teknova”) (Nasdaq: TKNO), a leading provider of critical reagents for the discovery, development, and ...
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