Food and Drug Administration (FDA)
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Sage announced the termination of the REDWOOD and RAINFOREST studies of zuranolone, which is being assessed to treat both major depressive disorder and post-partum depression.
The FDA’s Treosulfan rejection was surprising for both Meduxus and Medac. The FDA has provided a Complete Response Letter and made some recommendations.
The company announced that it is withdrawing its peripheral T-cell lymphoma drug Istodax from the market after recent trials showed that it does not achieve its primary efficacy endpoint.
The drug, created by Vaxart, has just completed its Phase I trial and had submitted an Investigational New Drug application to move forward.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
The company saw global net revenue of $13.9 billion during the second quarter, an increase of 33.9%. Sales were primarily driven by its immunology portfolio, which generated $6.12 billion.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The FDA has already given its go-ahead to use lumasiran to treat PH1 and lower the urinary oxalate levels in pediatric and adult patients under the brand name OXLUMO.
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company’s chronic kidney disease drug, tenapanor.
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