News

STAT2h
Will the FDA approve the first new drug to help people quit smoking in 20 years?
The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...
FDA appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
STAT1d
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
As FDA delays Novavax' COVID vaccine approval, patients fight back
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...
Fierce Biotech20h
FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
RFK Jr., FDA unveil 8 harmful dyes that will soon be phased out of US food supply — here’s what could be next
Over the coming months, the FDA will revoke authorization for two synthetic food colorings — Citrus Red No. 2 and Orange B — ...
FDA stops sale of copycat versions of Ozempic and Wegovy: What to do if you’re taking them
Many compounding pharmacies are no longer allowed to make cheaper versions of semaglutide and other GLP-1 drugs. A doctor ...