FDA
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The FDA issued a Complete Response Letter for its combination treatment of cabotegravir and rilpivirine.
Looking back over the past year and even decade, STAT News takes a look back at the best drugs approved over the past 10 years in its weekly Readout podcast.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
With the latest approval, Xtandi, an androgen receptor inhibitor, is now the only oral treatment approved by the FDA for three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
Vascepa capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid.
The FDA approved extended-release 11 mg and 22 mg tablets as a once-daily treatment from the chronic inflammatory condition.
The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look.
The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
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