Biotech Survey Sees Tough Days Ahead. Plus: Makary’s FDA Vision, China’s Speed Trials

Biotech Survey Sees Tough Days Ahead. Plus: Makary’s FDA Vision, China’s Speed Trials

On the latest BioCentury This Week podcast, the results of BioCentury’s Risk Sentiment survey By Jeff Cranmer, Executive Editor April 22, 2025 1:23 AM UTC The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey, with access to capital top of mind. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from …

Makary, in one of first comments on FDA policy, floats new pathway for rare disease drugs

It's been a little more than two weeks since Marty Makary took over as FDA commissioner and already he's announcing plans for a new, customized conditional drug approval pathway for therapies that could treat exceptionally ...

Where Does Rare Disease and Patient-Focus Fall into Commissioner Makary’s Priorities & the MAHA Platform for FDA? A New Ultrarare Approval Pathway & More

There is much change happening at FDA. In the wake of the April 1st reduction in force, there has been a great deal of uncertainty about what the impacts will be. This rings particularly true among…