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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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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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While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
FDA
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.