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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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Novartis’ canakinumab failed again in non-small cell lung cancer while Anixa Biosciences, Palisade Bio and Genexine kicked off new trials.
In the second half of the calendar year, the biopharma industry continues to ascend in mergers and acquisitions, new drug approvals and big investments, indicate market confidence and growth.
Cases of monkeypox infections reported in the latest viral outbreak have surpassed 14,000 in the U.S., according to the CDC. Some scientists believe the outbreak was predictable.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
With so many differences in research and regulation, it’s more important now than ever for job seekers considering moving outside of the U.S. to educate themselves before they make the leap.
Kymera has raised money through sale of more than 2,769,000 shares of common stock to help support the company’s ongoing clinical and preclinical programs.
New study supports link between Alzheimer’s and other diseases and points out potential risk factors for developing Alzheimer’s later in life.
Lundbeck revealed that its migraine drug Vyepti failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.
FDA
The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.