FDA Related News

Medical Devices

FDA Clears EBM Tech Radiological Image Reader

FDA clears an EBM Technologies 510(k) for its iPad Pro-based Rad System for diagnostic reading of radiological images.

Medical Devices

FDA Safety Issue with Paclitaxel-coated Balloons and Stents

FDA says it is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and pac...

Human Drugs

Complete Response Letter to Actelion for Opsumit sNDA

FDA issues Actelion Pharmaceuticals a complete response letter for its supplemental NDA for Opsumit (macitentan) for treating adults with inoperable c...

Human Drugs

Nexus Pharmas Generic Busulfex Approved

FDA approves a Nexus Pharmaceuticals ANDA for busulfan injection, the companys AP-rated therapeutic equivalent to Otsukas Busulfex 60 mg/10 mL (6 mg/1...

Human Drugs

FDA Develops 2 OTC Naloxone Drug Facts Models

FDA releases two models of drug facts labeling companies can use to speed applications for OTC naloxone.

Human Drugs

Clozapine REMS Updated

An FDA modification to the clozapine REMS takes effect 2/28, including requiring healthcare professionals and pharmacists who prescribe or dispense th...

Medical Devices

FDA Accepts Genentech sBLA for Tecentriq

FDA accepts for review a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with Celgenes Abraxane (albumin-bound paclitaxel; nab-...

Medtronic Enrolls 1st Embrace TDD Patient

Medtronic enrolls the first patients in its Embrace TDD study of the SynchroMed II intrathecal drug delivery system.

Human Drugs

Bridge Biotherapeutics Given Orphan Designation for BBT-877

FDA grants Bridge Biotherapeutics an orphan drug designation for BBT-877, an autotaxin inhibitor that deregulates ATX, an enzyme found to be associate...

Human Drugs

FDA. Omeros Agree on Phase 3 IgAN Trial

Omeros says it has reached agreement with FDA on a Phase 3 clinical trial plan for the companys OMS721 to treat immunoglobulin A nephropathy.