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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.
FEATURED STORIES
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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Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Genentech and privately-held Arsenal Biosciences forged a multi-year collaboration to identify critical success circuits in T cell-based therapies for solid tumors.
Pheon Therapeutics launched with $63 million in Series A financing and a vision of ushering in the next generation of antibody-drug conjugates.
TCR2 Therapeutics announced promising Phase I data for gavo-cel in mesothelin-expression that points toward effects in multiple solid tumors, especially ovarian cancer.
The anti-amyloid approach to treating Alzheimer’s disease is seeing new life after Eisai and Biogen announced that lecanemab slowed progression of disease in a Phase III study.
Funding initiatives this week saw money flow into cancer, rare liver diseases, respiratory depression, chemotherapy-related toxicities and a cutting-edge machine learning platform.
FUJIFILM Dyosynth Biotechnologies, Taysha Gene Therapies, Veravas highlight innovation stemming from the Lone Star state. BioSpace takes a deep dive into these and other Texas innovators.
Shares of Exicure, Inc. are falling after the company announced a strategic initiative that casts doubts on its future developmental programs.
The FDA ordered Avidity Biosciences to halt clinical trial enrollment after a patient suffered a “serious adverse event” testing the company’s candidate drug for myotonic dystrophy type 1.
The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
During an R&D presentation Tuesday, Transgene executives and oncology experts highlighted promising therapeutic progress in its programs - focusing on its developmental cancer vaccines.