FDA clears an MIM Software Inc. 510(k) for its molecular radiotherapy dosimetry.
FDA approves an Exelixis supplemental NDA for Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma who have been previously tre...
The Massachusetts attorney general says that members of the Sackler family that owns Purdue Pharma were instrumental in company efforts to push OxyCon...
FDA clears an iSchemaView 510(k) for its RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular ...
AdvaMed says updates to its code of ethics on interactions with healthcare professionals will take effect next 1/1.
FDA accelerates by two months the PDUFA review date for Nabriva Therapeutics Contepo antibiotic.
FDA orders about 400 inspectors and support professionals to return to their posts from furlough to re-initiate high-risk surveillance inspections acr...
FDA commissioner Scott Gottlieb looks at ways the agency is coping with an upswing in cell and gene therapy INDs.