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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

[ Price : $8.95]

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...

FDA Withdrawing Watson Labs Oxycodone Hydrochloride

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Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen...

FDA Withdrawing InvaGen Trandolapril ANDA

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Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.

FDA Regenerative Medicine Framework is Important Step: Pew

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A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says...

Court Rejects Innovator Liability in Generic Drug Case

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Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company ca...