When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...
MyChesCo on MSN
NRx reports FDA guidance on NRX-100 approval path
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said it received guidance from the U.S. Food and Drug Administration ...
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry ...
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...
The MarketWatch News Department was not involved in the creation of this content. LEWES, Del., Jan. 21, 2026 (GLOBE NEWSWIRE) -- John Snow Labs, a healthcare AI company, today announced that its ...
The trouble with FDA's move to require only one study for new drugs ...
LEWES, Del., Jan. 21, 2026 (GLOBE NEWSWIRE) -- John Snow Labs, a healthcare AI company, today announced that its Patient Journey Intelligence (PJI) platform is the first secondary-use data platform ...
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