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Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
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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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A California judge denied Elizabeth Holmes’ motion for release pending appeal, ruling that the former Theranos CEO must serve her prison sentence while she appeals her guilty verdict.
Data from two mid-stage studies show HI-Bio’s investigational therapy felzartamab lowers pathogenic antibody titers in patients with primary membranous nephropathy (PMN).
Karuna Therapeutics’ KarXT and Acadia Pharmaceuticals’ pimavanserin are sparking hope that a treatment for the negative symptoms of schizophrenia could be on the horizon.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.
The Boston Business Journal reported the layoffs would affect the multiple sclerosis team, but Biogen declined to confirm the details.
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.