cell and gene therapies

News

FDA removes barriers to cell, gene therapy development

FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.

News

FDA unveils swift route to market for personalised drugs

FDA reveals a regulatory pathway for personalised therapies based on 'plausible mechanism', drawing on the bespoke gene-editing treatment of Baby KJ.

News

Bayer starts pivotal Parkinson's cell therapy trial

Bayer's much-anticipated stem cell therapy for Parkinson's disease is gathering momentum, with dosing in phase 3 trials now underway.

News

Cellular Origin's Constellation robotic system for cell and gene therapy manufacturing

UK project addresses capacity issue in CGT manufacturing

A UK consortium has been set up to tackle a major issue in the development of cell and gene therapies (CGT) – a lack of manufacturing capacity.

News

FDA blocks trials that send US cells to 'hostile' countries

The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as the agency's leadership in this area is sidelined.

R&D

Woman, microscope and scientist in research

Advances in manufacturing in vivo lentiviral vectors: Challe...

Lentiviral vectors (LVVs) have proven to be extremely versatile genetic delivery vehicles, gaining space as a gene transfer technology tool used both for cell and gene therapies.

FDA removes barriers to cell, gene therapy development

FDA unveils swift route to market for personalised drugs

Bayer starts pivotal Parkinson's cell therapy trial

UK project addresses capacity issue in CGT manufacturing

FDA blocks trials that send US cells to 'hostile' countries

Advances in manufacturing in vivo lentiviral vectors: Challe...

FDA approves higher Wegovy dose via 4th priority voucher

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cell and gene therapies

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