ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for ...
In an interview with Reuters, the FDA’s commissioner, Scott Gottlieb said the agency is “re-evaluating and modernising” its approach to nicotine replacement therapies (NRT), typically sold ...
Nicotine pouches like Zyn are getting increasingly popular but aren't FDA-approved to help quit smoking. Josh Brolin loves his nicotine pouches and he's not afraid to show it. On Thursday's ...
Her expectation is that once the FDA completes its review of the premarket tobacco product applications (PMTAs) for the category and determines that an oral nicotine pouch is appropriate for the ...
The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of ...