New tobacco products must submit a PMTA and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to ...

Conavi Medical has submitted its Novasight Hybrid™ IVUS/OCT intravascular imaging system to the US Food and Drug ...

NDA remains on track for FDA PDUFA goal date of January 31, 2026 Commercial planning continues enabling rapid launch following approval WARREN, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive ...

Conavi announced today that it submitted its next-generation Novasight Hybrid intravascular imaging system for FDA 510(k) ...

These pioneers are aiming to do challenging and important medical work. One has already implanted 54 patients.

Submission Follows the Successful Validation Testing with KOLs FDA 510(k) Clearance Anticipated During H1 2026 and Company ...

But today, thanks to a research lab at California Institute of Technology (Caltech) that implanted him with a brain computer interface ... Food and Drug Administration (FDA), including some staff ...

Apple unveils iPhone 17 lineup, new AirPods Pro, and upgraded smartwatches ahead of the holiday shopping season. Newsweek's ...

The agency held a meeting to gather drugmakers' perspectives as it considers a draft guidance on how previously generated ...

Introduction The global market for electronic cigarettes (e-cigarettes) has been changing rapidly. There is limited research ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' Abbreviated New Drug Application (ANDA) for ...