The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming ...
The FDA's approval of Zepbound provides a new approach to treatment for Americans who struggle with OSA and obesity. Patients considering Zepbound should discuss the potential benefits ...
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FDA grants IDE approval for NextBioMedical’s Nexsphere-F trialThe US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical's ...
The MEL 90 fully integrates into the Corneal Refractive Workflow to offer U.S. surgeons a fast, reliable, and streamlined ...
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
With Clearlight's Red Light Therapy Personal Tower, you can steal the spotlight with your own red carpet-worthy glow.
The FDA has granted fast track designation for abenacianine to help surgeons better visualize lung tumors during minimally ...
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