cell and gene therapies

News

The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.

Oncology

After the Advanced Therapies Congress, Europe, pharmaphorum spoke with Resolution Therapeutics' Lara Campana and Vianautis' Dr Sam Barker.

News

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

News

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

News

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.