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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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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
Angion Biomedica Corp. discontinued a Phase II kidney disease trial while Novo Nordisk missed the mark in a NASH study.
BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.
As the nation reacts to the overturning of Roe v. Wade, pharma companies must address the changes in demand for drugs and services, all while navigating increasingly muddy legal waters.
Although the company promised strong sales-based resources for the launch of dry eye drug Tyrvaya, the streamlining plan will include laying off up to 50 employees.
Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover’s homologous booster against Omicron increases antibodies, and much more.
89bio reported positive topline results from ENTRIGUE Phase II trial of pegozafermin in patients with severe hypertriglyceridemia.
This week money went towards more advanced rounds of financing for drugs and technology that have already shown a lot of promises.
Axsome hosted an investor day event to provide an update on plans for Sunosi and other developmental assets, including MDD treatment AXS-05.
Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Generian and Mitobridge, a wholly-owned subsidiary of Astellas Pharma, announced a collaboration to discover and develop novel small molecules for undruggable therapeutic targets.