Ropes & Gray attorneys outline key provisions in an FDA final guidance on multiple function medical devices.
The CDER Office of Prescription Drug Promotion says a TV ad for Xeris Gvoke fails to provide important risk information but misrepresents the products...
Bloomberg News says a Bayer product surveillance senior manager warned the company that FDA would be notice an increase in adverse event reports again...
FDA approves a Novartis NDA for Kesimpta (ofatumumab) for subcutaneous use to treat relapsing forms of multiple sclerosis.
FDA updates its alert on breast implant adverse events to include new reports received through 1/5 an increase of 160 new cases and three deaths sinc...
FDA reports a slightly increased risk of non-melanoma skin cancer in patients taking the diuretic hydrochlorothiazide.
Federal Register notice: FDA sends to OMB and information collection extension for Customer/Partner Service Surveys.
FDA approves Janssen Biotechs Darzalex (daratumumab) in combination with Amgens Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multi...