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Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
Vertex Pharmaceuticals VRTX announced that the FDA has approved its next-in-class vanza triple therapy for treating people ...
Health Affairs24d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
This is in contrast to accelerated approval for ... devices that are FDA-cleared through the 510(k) pathway do not demonstrate, or even attempt to demonstrate, robust evidence of clinical utility ...
Business Insider25d
Promising Prospects for Clene’s ALS Treatment: Buy Recommendation Backed by Robust Data and Regulatory Progress
which could accelerate the approval process. The ongoing engagement with the FDA and the robust data, including over 500 years of patient exposure, highlight the product’s potential in ...