Approvals
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.
The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline.
PRESS RELEASES