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Biogen Gains Vumerity Approval for MS

[ Price : $8.95]

FDA approves a Biogen NDA for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis.

Breakthrough Status for Enhanced Pulse Oximeter

[ Price : $8.95]

FDA grants Breakthrough Device status to Med-botics for its Oxalert EPO (Enhanced Pulse Oximeter), a wrist-worn arousal device des...

Impulse Dynamics New Optimizer Smart System OKd

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FDA approves an Impulse Dynamics PMA supplement for its next generation of the implantable Optimizer Smart System for delivering c...

FDA Flexible in Weighing Medical Device Uncertainty

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CDRHer Charles Viviano explains on a Webinar a new guidance on how the Center is flexible in weighing uncertainty in making medica...

Ethicon Echelon Flex Stapler Recall is Class 1

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FDA says an Ethicon recall of its Echelon Flex staplers is Class 1.

Woodcock Pushes Advanced Drug Manufacturing Technologies

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CDER director Janet Woodcock says advanced manufacturing technologies could reduce U.S. drug maker reliance on foreign-sourced act...

PET Drug CGMP Issues at Petnet

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FDA warns Petnet Solutions about CGMP violations in its manufacturing of positron emission tomography drugs.

National Center for Toxicological Research Panel Meeting 12/3-4

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Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory ...

Class 1 for Continuous Glucose Monitor Data Systems

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Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).

AstraZeneca Positive Results for Imfinzi in Lung Cancer

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AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV ...