MedCity News January 2, 2025
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.
For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA.
Notable regulatory decisions include the first drug approval for a prevalent chronic condition and a novel regenerative medicine approach to help trauma patients. In one case, a new drug approval comes as its developer takes on a new identity in the new year.
Here’s a look back at some highlights from a busy regulatory month:
Notable Firsts
—The prevalent sleeping disorder obstructive sleep apnea has historically been managed with a medical device that helps...
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