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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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AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
Amgen announced two lung cancer studies with mixed results, Innovent dosed the first patient in a Phase I diabetic macular edema study and HUTCHMED hit the primary endpoint in colorectal cancer.
This week’s Movers & Shakers include Scribe, Appia Bio, Chimerix and KemPharm, all announcing new VP roles. Companies also plan for the future with the implementation of a succession plan.
The makers of ranitidine-based products, such as Sanofi, GSK and Haleon, are reeling from lawsuits related to carcinogenic contamination that could result in billions of dollars in damages.
Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.
A new study on Alzheimer’s disease ties the brain’s immune response to the condition, while scientists have identified a better antibody treatment for cancer and more research news.
Panacell Biotech plans to initiate a program to investigate the use of natural killer (NK) immune cells, exosomes and brown adipose-derived stem cells to treat Long COVID.
Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Versant Ventures launched Vector BioPharma, a company developing a “precision gene delivery platform that is devoid of viral genes.” Rani, REVA Medical and Summit Therapeutics also scored funds.