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FDA
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.
IPO
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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Seagen recently presented positive pivotal Phase II data from its trial of Tukysa (tucatinib) in combination with trastuzumab in HER2-positive metastatic colorectal cancer.
Dynacure has ended its Unite-CNM Phase I/II trial on DYN101, an investigational therapy for the treatment of myotubular and centronuclear myopathies.
Ayala announced positive data for its desmoid tumor treatment, while Vertex and Dyne announced the FDA had lifted the hold on their clinical studies.
Last year, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
In a filing with the SEC, Abbvie’s decision to terminate came after the two firms jointly conducted a review of their next steps for the drug.
With one in three employed women in the U.S. also raising children at home, and the majority of U.S. moms working at least part-time, moms are working overtime to keep up with their male counterparts.
Ramesh “Sunny” Balwani, Elizabeth Holmes’ former business and romantic partner, was found guilty of all 12 fraud charges brought against him for his role in the Theranos scandal.
Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
With COVID-19 vaccination rates dropping, millions of doses are going to waste. Meanwhile, outdoors isn’t sure-fire protection but long-term intermittent fasters may be spared severe disease.
Adagio, Aravive, PolyPid, Harpoon, Durect, Nitrase, Kallyope, TScan and many more made major leadership decisions this week.