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Janssen Files NDA for Invokana/Metformin Combination

[ Price : $8.95]

Janssen Research and Development files an NDA for Invokamet XR, a once-daily therapy combining fixed doses of its Invokana canagli...

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

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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

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

Liptruzet Not Withdrawn for S&E

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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

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

Major Review Concerns on Kyndrisas Safety/Efficacy

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FDA reviewers express major safety/efficacy concerns that may hamper approval of a Biomarin NDA for Kyndrisa (drisapersen) for tre...