FDA commissioner Scott Gottlieb says the agency is listening to patients on how loperamide restrictions may affect them.
FDA clears a C4 Imaging 510(k) for its second major brachytherapy product, the HDR MRI Marker.
Drger Medical recalls its Fabius Anesthesia Machines due to a potentially fatal production step error.
A House Appropriations subcommittee votes to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current...
Pacira Pharmaceuticals petitions FDA not to approve any NDA for a fixed-dose combination of bupivacaine and meloxicam without sufficient evidence of s...
FDA issues a draft guidance on how drug supply chain trading partners can request a waiver, exception, or exemption from some specified requirements.
FDA approves a Janssen supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients w...
A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assis...