FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used ...
Innovate Shares Gain After FDA Approves Kidney-Function Assessment Device
Shares of Innovate rose after the Food and Drug Administration approved the company's device to assess kidney function. The stock was 43% higher, at $7.30, midday Tuesday, the first day of trading ...
Scilex Holding Company Announces that It Regains Nasdaq Compliance Under Listing Rule 5250(c)(1)
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido ® is a registered ...
Innovate Corp. stock soars on FDA approval
Shares of Innovate Corp. (NYSE:VATE) surged 60% following the announcement that the U.S. Food and Drug Administration (FDA) ...
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FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
FDA proposes mandatory front-of-package nutrition labels to combat spike in chronic diseases
The U.S. Food and Drug Administration (FDA) is demanding increased, in-your-face food transparency when it comes to nutrition ...