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Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Microgravity offers unique advantages when investigating cells and proteins, but collaboration and a strong ethical framework are needed to fully realize its benefits.
The company is ending its program evaluating antibody-drug conjugate tusamitamab ravtansine after a non-small cell lung cancer trial did not meet a primary endpoint.
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
The biotech’s investigational COMP360 psilocybin treatment showed positive safety and tolerability with no serious adverse events in a mid-stage study of people with post-traumatic stress disorder.
A study finds that employees are more likely to view pay for performance positively—and rise to the challenge of performing well—when they view their managers as friendly and good at their jobs.
Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.
Gene therapy company uniQure announced Tuesday “ongoing evidence” of a clinical benefit for its Huntington’s disease treatment. However, investors were not impressed as the stock dropped nearly 20%.
On this episode of the Weekly: Biden administration puts pressure on the biopharma industry; renewed interest in psychedelics after MindMed announces LSD-based candidate meets primary endpoint; bluebird changes its tune.