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FDA clears a Neurovalens 510(k) for its Modius Sleep neurostimulation device for treating chronic insomnia.[ Price : $8.95]
Federal Register notice: FDA determines that Novartis Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn ...[ Price : $8.95]
CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...[ Price : $8.95]
Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence o...[ Price : $8.95]
Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuti...[ Price : $8.95]
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three e...[ Price : $8.95]
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker...[ Price : $8.95]
FDA posts a final guidance entitled Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.