Food and Drug Administration (FDA)
NEWS
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.
The FDA granted Astellas Pharma and Seattle Genetics accelerated approval for Padcev, a first-of-its-kind treatment for adult patients with metastatic urothelial bladder cancer.
Adamas Pharmaceuticals reported that its Phase III INROADS trial of Gocovri (ADS-5102) for multiple sclerosis (MS) with walking impairment met its primary endpoint. That would seem to be good news, but the trial failed to meet secondary measures which worried investors, causing shares to drop by 45%.
Follows recent study results showing CelGro® facilitates high quality nerve repair and restores function to previously paralysed muscles
PERTH, AU, Dec 13, 2019 - - Holista CollTech announced that it has filed its 100%-owned global patent for platform technology that will deliver many fat-soluble medications by creating a water-soluble delivery system.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
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 U.S. Senate confirmed Hahn as the new commissioner Thursday in a 72-18 vote.
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