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FDA
It’s official: FDA Commissioner Marty Makary is out at the FDA after reports of his ouster emerged late last week; Sanofi is reportedly having challenges with one of the FDA’s new signature programs; and biopharma CEOs’ multimillion-dollar salaries ticked up again this year. Who made the most in 2025?
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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.
New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
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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
In a bid to win back investor confidence, Illumina on Tuesday unveiled a three-year growth plan focused on easier DNA sequencing and improved data analysis for customers.
Eli Lilly’s new research and development facility in Boston’s Seaport district will focus on DNA- and RNA-based therapies, as well as other priority areas such as diabetes and obesity.
Rivus Pharmaceuticals will push HU6 into Phase III development and is looking to engage with regulatory authorities and launch a late-stage study next year in obesity-related heart failure with preserved ejection fraction.
Plus, learn how to handle vacation time in a new job and navigate the stress of a recent promotion to leadership.
Lykos Therapeutics will ask the FDA to reconsider its rejection of the company’s MDMA-assisted PTSD therapy, Pfizer scores positive Phase III results for its RSV vaccine, a roundup of Q2 earnings season and more.
On the heels of last week’s FDA rejection of Lykos’ MDMA-assisted PTSD therapy, Atai announced Tuesday positive preliminary results for its DMT-based treatment for depression from a Phase Ib study.
While some biopharma companies beat expectations, others fell short for various reasons, with some deciding to return or axe assets.
The layoffs are intended to help provide an operating runway into the fourth quarter of 2026.
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.