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Philips Recalls Forte Gamma Camera System

[ Price : $8.95]

Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.

RedHill Bio Gains H. Pylori Approval

[ Price : $8.95]

FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for tr...

DiFusion Spinal Interbody Device Cleared

[ Price : $8.95]

FDA clears a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device.

Abbott Recalls CentriMag Circulatory Support System

[ Price : $8.95]

Abbott recalls its CentriMag Acute Circulatory Support System due to a calibration system error.

Aveo Planning Tivozanib NDA Despite FDA Objections

[ Price : $8.95]

FDA says a requested clinical trial did not alleviate an overall survival trend that it was concerned with in an earlier Aveo Onco...

Aquestive Therapeutics Asks Approval Stay for Valtoco

[ Price : $8.95]

Aquestive Therapeutics asks FDA not to approve Neurelis Valtoco until the company performs additional studies like those Aquestive...

Tonix Changes Tonmya Phase 3 Study

[ Price : $8.95]

Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD tr...

Abernathy Overhauling FDA Tech Infrastructure: Politico

[ Price : $8.95]

FDA principal deputy commissioner Amy Abernathy says the agency is overhauling its technology infrastructure to be prepared to cop...

FDA Updates Essure Post-Market Activities

[ Price : $8.95]

FDA updates its online records on post-market activities and studies of Bayers withdrawn Essure birth control device.

Latest Federal Register Notices

[ Price : $8.95]

FDA Review posts the Federal Register notice for the week ending 8/1/2019.