In a landmark moment for pediatric oral health, Velura, a leader in innovative natural wellness products, today unveiled ...
Augurex’s Spinestat diagnostic test earned the FDA’s breakthrough device designation. Spinestate is a 14-3-3eta autoantibody multiplex immunoassay test for diagnosing axial spondyloarthritis, ...
An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the ...
UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...
Developers of biosimilars will no longer be required by the FDA to conduct clinical trials to prove effectiveness.
Changes strategically aligned to support planned launch of Anaphylm™ (dibutepinephrine) Sublingual Film, if approved by the FDA, and to ...
The discussion will focus on the Company’s product candidate Anaphylm™ (dibutepinephrine) Sublingual Film, including regulatory progress and commercial readiness. Aquestive management team ...
Opinion
A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway
This is not just about one device. It’s about what happens when institutions grow comfortable living in their own ambiguity and hiding behind opacity.” ...
The trial, which is partially funded by $5 million in taxpayer money allocated by the Arizona Legislature and Gov. Katie ...
The Food and Drug Administration (FDA) has put four companies on notice for marketing “unapproved fluoride-containing ingestible drugs” for use by children under the age of 3 or children at low or ...
The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some ...
The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure ...
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