Biotech Looks to Replimune RP1 Decision as ‘First Indicator’ of FDA Direction
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent....
Eli Lilly (NYSE: LLY) won the approval it sought when the FDA authorized the company’s oral obesity drug Foundayo (orforglipron), but the pharma giant’s post-approval stock...
While the opioid epidemic is one of the most urgent public health emergencies facing the U.S., new therapeutic approaches for treating the underlying substance use disorder...
Welcome back to Endpoints Weekly! They say March comes in like a lion and out like a lamb, but two pharma giants made a roar this...
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Biomedical researchers headed by a team at the Lampe Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill/North Carolina State University, have developed...
Scientists from The Jackson Laboratory (JAX) and their collaborators elsewhere have found a potential way to treat cases of acute myeloid leukemia that involves turning a...
The White House is asking Congress to cut $5 billion from the National Institutes of Health and to downsize the number of its institutes and centers...
“Section 232” national security levies won’t apply to a wide array of drugs, meaning the “overall threat to the sector should be low,” according to one...