FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast cancer with leptomening...
FDA releases a final guidance entitled Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theor...
FDA reissues a guidance document entitled Process to Request a Review of FDAs Decision Not to Issue Certain Export Certificates for Devices.
FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.
Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn due to safety or eff...
CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical device security - Securit...
Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence of chlorhexidine in t...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for treating adults...
