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An FDA advisory committee voted unanimously, 13 to 0, on Friday to recommend Bluebird Bio’s investigational gene therapy betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood cell transfusions. Read More
As Congress continues to search for ways to rein in prescription drug costs, a new study published in JAMA this week showed that the price of new medicines has spiked from a median price of $2,115 per year in 2008 to $180,007 per year in 2021. Read More
AstraZeneca is aiming to expand the use of its dual-antibody COVID-19 treatment Evusheld (tixagevimab–cilgavimab) to nonhospitalized patients with mild-to-moderate COVID 19 based on data from a late-stage study that showed it reduced the risk of progression to severe disease or death by 50 percent in a group of unvaccinated patients at high risk of poor outcomes. Read More
With 392 ayes and 28 nays, the U.S. House of Representatives passed a package of legislation late Wednesday to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device user fee programs. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic combination products if the generic product’s user interface is substantially different from the original product. Read More