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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.
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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Of the 30 patients given CellTrans’ Lantidra in two studies, 21 were insulin-free for at least a year and 10 were insulin-free for more than five years.
Phase I/II data on AbbVie and Genmab’s recently approved bi-specific antibody in a second cancer indication positions them to talk to regulators about filings to challenge Roche’s Lunsumio.
The company halted studies of the treatment for a rare, advanced form of eye cancer after clinical results showed just one response in 47 patients.
The funds will support a trial of a tuberculosis vaccine developed by GSK that could potentially be the first new TB shot in a century.
Providing extra benefits and perks to parents in the workplace can be polarizing, but it doesn’t have to be.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
While early, the Phase I study results for 12 patients represent a promising return on Bayer’s investment in BlueRock, which it launched with Versant Ventures in 2016 and fully acquired three years later.
Overcoming an FDA rejection in January 2022, Pfizer and OPKO’s Ngenla will provide a long-acting, reduced-frequency treatment option for children with growth hormone deficiency.
The U.S. Equal Employment Opportunity Commission settled with Eli Lilly for $2.4 million after filing a suit in September over the company’s recruitment of younger workers.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.