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After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.
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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.
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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Eliem Therapeutics is dropping a depression drug candidate and laying off 55% of staff in an attempt to stretch its cash runway to 2027.
The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities in its Helicobacter pylori drug products.
Vertex Pharmaceuticals is marching toward the launch of exa-cel with a lot of confidence, per its full-year 2022 presentation.
Amid mounting pressure from investors and shareholders, Bayer’s supervisory board unanimously appointed outsider Bill Anderson as its new CEO.
With just under 98,000 tech employees laid off just one month into 2023, many in the life sciences are likely wondering if biotech layoffs will reach similar peaks.
The FDA’s Oncologic Drugs Advisory Committee voted 8-5 that two single-arm trials would be “sufficient to characterize the benefits and risks” of Jemperli in locally advanced rectal cancer.
Trade secrets litigations and disputes have been on the rise in recent years, and given the FTC’s recent proposal to ban all non-compete agreements nationwide, the trend is likely to continue.
Amid growing demands for generic versions of Vertex’s Trikafta, the company provided an update on the late-stage clinical development of its next-in-class triple combination for cystic fibrosis.
Though there is no sure-fire tell, there are a few signs to look out for that indicate leadership could be planning to cut staff. Here are the signs layoffs may be coming soon at your organization.
Bristol Myers Squibb has returned the rights for interleukin-12 immunotherapy program DF6002 back to its original owner, Dragonfly Therapeutics, the companies announced Monday.