FDA

R&D

In today’s episode, host Jonah Comstock speaks with Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma.

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.

Market Access

Policy experts Alice Valder Curran and Elizabeth Jungman of Hogan Lovells weigh in on Trump's MFN deals, FDA vouchers, and the government shutdown.

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

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.