USpolicy

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

GLP-1 drugs for weight loss, cancer, and rare diseases feature among the latest crop of medicines awarded priority vouchers by the FDA.

News

The pricing agreement between Novo Nordisk and Eli Lilly and the Trump administration on GLP-1 drugs for diabetes and obesity has arrived.

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

People living with thymidine kinase 2 deficiency (TK2d), a vanishingly rare and often fatal genetic disorder, finally have an approved therapy.