CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

BioMarin Pharmaceuticals is one of many biotech companies that’s laid off workers over the past two years. Its office in ...

Since Dr. Vinay Prasad’s appointment as a key political voice within FDA, the tone of U.S. biotech policy has shifted from ...

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated ...

The FDA's 'Elsa' AI, intended to speed up drug approvals, is reportedly fabricating studies, part of a wider trend of ...

Two months after laying off 20% of its staff, Korro Bio says it has not retreated from its “3-2-1” corporate strategy as it prepares to release interim clinical data on its lead candidate KRRO-110 in ...

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Brad Stewart, BDO’s national life ...

The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising ...

Thousands of workers at federal health agencies lost their jobs this week after a US Supreme Court ruling cleared the way for the Trump administration to move forward with major staffing cuts.

Other agencies are moving forward with RIFs and terminations, but official tells federal court some plans have changed.

The investigative unit, which looks into potential safety issues with drugs, vaccines, medical devices, and other products, has had a retention problem for years. Inspectors leave so often that, even ...

Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.