FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.
FDA approves Sebelas Suflave colonoscopy prep that reportedly tastes like a sports drink and thus is easier to use.
Five stakeholders express appreciation for a revised FDA draft guidance on pharmacogenomic data submissions and suggest changes to it.
Thirteen state attorneys general call on FDA to develop a plan for disposal of opioid drugs that includes at-home, single-use disposal products.
Senator Marco Rubio questions FDAs decision to temporarily permit the importation of unapproved cisplatin, an important chemotherapy drug in short sup...
FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments for improving bloo...
Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain patients access to care...
Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Progr...
