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Event Medical Class 1 Recall of Inspiration Ventilators

[ Price : $8.95]

Event Medical begins a Class 1 recall of its Inspiration Ventilator System, i Series and LS 12.1 LCD models because a component on...

FDA Approves Takedas Ninlaro for Multiple Myeloma

[ Price : $8.95]

FDA approves a Takeda Pharmaceuticals NDA for Ninlaro (ixazomib) for combination use with two other therapies to treat people with...

FDA Posts 4 Guidances on Suncreen Testing

[ Price : $8.95]

FDA releases four draft guidances as required by the Sunscreen Innovation Act that provides the agencys current thinking on the sc...

More Concerns on Califfs Role in Xarelto Trial: POGO

[ Price : $8.95]

Duke Clinical Research Institute reexamines a study overseen by FDA commissioner-nominee Robert Califf amid concerns of potentiall...

Liptruzet Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Liptruzet tablets 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg were not wit...

FDA Reclassifies Salivary Stimulator

[ Price : $8.95]

Federal Register Final order: FDA reclassifies the salivary stimulator system into Class 2 and renaming it the electrical salivary...

FDA Classifies UV Radiation Chamber into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the ultraviolet radiation chamber disinfection device into Class 2.

FDA Exempts Electric Chair Devices

[ Price : $8.95]

Federal Register Final order: FDA grants a petition seeking exemption from premarket notification requirements for electric positi...

St. Judes Proclaim Spinal Cord Stimulator for Pain Approved

[ Price : $8.95]

FDA approves a St. Jude Medical PMA for the Proclaim Elite Spinal Cord Stimulation System, which the company describes as the firs...

FDA Approves Adapts Narcan Nasal Spray

[ Price : $8.95]

FDA approves an Adapt Pharma NDA for Narcan (naloxone hydrochloride) nasal spray, the first FDA-approved nasal spray indicated to ...