AveXis has posted top-line data from a phase 1 trial of its gene therapy against spinal muscular atrophy (SMA). All 15 patients were event-free at 13.6 months…

President Donald Trump’s first budget has not gone down well with the medical research and regulatory communities, which have come out against his plans to cut…

Seres Therapeutics has unveiled the design of a phase 2 trial it thinks could secure FDA approval for its microbiome drug.

President Donald Trump’s first budget will take billions of dollars away from the National Institutes of Health (NIH) as the administration looks to rein in…

Karyopharm has seen studies for its big hope selinexor placed on a partial clinical hold, meaning it can no longer recruit new patients, over the FDA’s demands…

President Donald Trump has chosen Scott Gottlieb to run the FDA, setting the stage for faster approvals, greater regulatory transparency.

Ionis saw its share price fall 8% after it posted results from a phase 3 trial of its antisense drug volanesorsen in familial chylomicronemia syndrome.

Advaxis and Amgen get an FDA OK to start testing their neoantigen cancer vaccine, partnered in a $540 million deal last year.

Sanofi and Regeneron have taken a deeper dive into phase 3 data on hotly tipped atopic dermatitis drug dupilumab.

Regulatory