Leading vaccine experts sharply criticize a new FDA memo that claims ten children died after and because of receiving Covid-19 vaccines between 2021 a...
Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivotal trial in patient...
FDA says it has deployed advanced agentic AI capabilities to all agency employees, marking a major expansion of its artificial intelligence tools for ...
FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.
Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications...
FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat edema in adults wit...
Novo Nordisk files a supplemental NDA seeking approval for a higher-dose version of weight-loss drug Wegovy (semaglutide).
A law journal article, discussed in Regulatory Review, proposes a framework courts could use to consider state challenges to federal preemption of dru...
