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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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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.
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Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
Whistleblowers Erika Cheung and Tyler Shultz discussed their experiences at Theranos during the recent 2022 AACC Annual Scientific Meeting & Clinical Lab Expo.
AbbVie and Sosei add neurological targets in new deal, TransCode and MD Anderson partner on RNA cancer therapies and Xenetic and VolitionRx unite to develop NETs-targeted therapies against cancer.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
The annual Alzheimer’s Association International Conference (AAIC) is running from July 31-August 4 at the San Diego Convention Center and online. Here are some of the highlights presented so far.
According to two recent studies, 10 to 30% of people with COVID-19 reported at least one persistent symptom up to six months after infection, which qualifies as Long COVID.
The exact implications of the paxalisib disappointment are still unclear, though it is highly likely that the candidate will be dropped from the GBM AGILE umbrella trial.
IDRx aims to create highly selective and aligned drug combinations to stop key tumor escape mechanisms that will support prolonged and durable responses to therapy.
The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The decision comes after the FDA put NUV-422, its candidate for high-grade gliomas, on a partial clinical hold, citing safety concerns.