FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Empirical Spine PMA for Spinal Tension Band

[ Price : $8.95]

Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from d...

Medtronic Recalls Valiant Navion Thoracic Stent Graft

[ Price : $8.95]

Medtronic recalls all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device unt...

Brain-protecting Sports Collar Authorization

[ Price : $8.95]

FDA grants a de novo marketing authorization to Q30 Sports Science for its Q-Collar, a device intended to be worn around the neck ...

Amneal Pharma Generic Ortho Evra Approved

[ Price : $8.95]

FDA approves an Amneal Pharmaceuticals ANDA for 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol transdermal system, a ...

Braun Medical IV Bag Acetaminophen OKd

[ Price : $8.95]

FDA approves B. Braun Medicals acetaminophen injection in IV bags in 1,000 mg in 100 mL and 500 mg in 50 mL doses.

FDA Seeks More Data on Merck Covid Drug

[ Price : $8.95]

FDA asks Merck for additional data beyond a recently completed Phase 3 study of investigational Covid-19 drug MK-7110, an immune m...

FDA Panel Backs EUA for Janssen Covid Vaccine

[ Price : $8.95]

An FDA advisory committee votes 22-0 to support an emergency use authorization for Janssen Biotechs single intramuscular Covid-19 ...

GC Pharma BLA for Humoral Immunodeficiency

[ Price : $8.95]

GC Pharma submits a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral imm...

7 NADAs Withdrawn Over Reporting Requirements

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect the withdrawal of approval of seven new animal drug app...

Humira OKֺd for Pediatric Ulcerative Colitis

[ Price : $8.95]

FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for treating moderately to severely active ulcerative colitis in p...