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FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.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...
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gas...
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasi...