FDA removes a clinical hold against two Immuron trials of Travelan, an orally administered passive immunotherapy that prophylactically reduces the lik...
FDA grants Singlera Genomics a breakthrough device designation for its PDACatch assay, a DNA methylation-based liquid biopsy assay for detecting pancr...
FDA approves Eyenovias Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedures.
FDA announces a 5/11-12 workshop entitled Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop.
FDA clears a Samsung Electronics 510(k) for its Irregular Heart Rhythm Notification feature on its Health Monitor app for Samsung Galaxy watches.
FDA grants Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Covid-19 serology tests.
FDA commissioner Robert Califf warns that large language models (ChatGPT) and their use by industry will require regulation because the agency runs th...
FDA posts a consent decree non-compliance letter to Sun Pharma outlining inspectional findings at the companys Mohali (Punjab), India manufacturing fa...
