News Sarepta rises after FDA adds warning label to Elevidys Uncertainty ends Sarepta's Duchenne gene therapy Elevidys ends after an FDA label update, with the company's shares on the up despite restrictions.
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 FDA appoints veteran Pazdur to replace Tidmarsh 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-1s feature in second batch of national priority vouchers GLP-1 drugs for weight loss, cancer, and rare diseases feature among the latest crop of medicines awarded priority vouchers by the FDA.
News Novo, Lilly sign MFN pricing deal with Trump administration The pricing agreement between Novo Nordisk and Eli Lilly and the Trump administration on GLP-1 drugs for diabetes and obesity has arrived.
News Dismay as FDA declines to approve Biohaven's ataxia drug 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.
R&D Working together to innovate on pragmatic clinical trials, w... In today’s episode, host Jonah Comstock speaks with Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma.
Sales & Marketing Sponsored How to meet your physicians where they are online A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.