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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
Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.
Finch announced that it is slashing its headcount by around 37% and suspending its planned Phase I study in autism a week after Takeda withdrew from its multi-year collaboration.
The Administrative Law Judge overseeing the FTC’s challenge of Illumina’s acquisition of Grail rejected the regulator’s anti-competition argument, Illumina announced Thursday.
It’s been a busy week for research on rare diseases, with several clinical trials from AnaptysBio, Regenxbio, Sangamo and more posting results from ongoing activities.
A cell and gene therapy accelerator formed by Mayo Clinic, Hibiscus BioVentures and Innoforce is officially up and running, the partners announced this week.
Hard times are forcing biopharma companies to extend their runways as they try to eke out every cent of value from their capital.
Biopharma and life sciences companies, such as Seraxis, Verily and Vaxart, tap new members to bolster their leadership teams in roles like CMO, CTO, CCO, and more.
Shares of AnaptysBio are down more than 16% after imsidolimab failed to meet the endpoint in a Phase II trial assessing its efficacy in hidradenitis suppurativa.
Provention Bio secured a $125 million loan from Hercules Capital that will support operations and the potential launch of the company’s type 1 diabetes treatment, teplizumab.
Novo Nordisk has entered into an agreement to acquire Forma Therapeutics for $1.1 billion. Forma’s lead development candidate, etavopivat, is being developed for sickle cell disease.