regulatory

News

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

News

The FDA has steadied the ship at CDER by naming veteran regulator Richard Pazdur as director, although he was reportedly reluctant to take the job.

News

The battle for obesity drug developer Metsera rumbles on, with Pfizer reported to have now matched Novo Nordisk's $10 billion offer.

News

Biohaven's troriluzole candidate for spinocerebellar ataxia (SCA) has been turned down by the FDA, in another sign of a tougher stance by the agency.

News

uniQure has revealed that the FDA has said it is not prepared to review its Huntington's gene therapy in what seems to be a change in policy.

R&D

Automation holds the potential to enhance scientific rigour and operational efficiency while solving long-standing regulatory conundrums.