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Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn due to safety or eff...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...
Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuticals vigabatrin oral...
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three eye disease indicatio...
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for treating adults...
