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Medtronic Spine Rods Cleared by FDA

[ Price : $8.95]

FDA clears a Medtronic 510(k) for patient-specific UNiD Rods for use with its CD Horizon, Solera, Voyager and Infinity OCT spinal ...

FDA Priority Review for Amryt Oleogel-S10

[ Price : $8.95]

FDA grants priority review for an Amryt NDA for oleogel-S10 to treat epidermolysis bullosa.

Dermavant NDA Filed for Psoriasis Drug

[ Price : $8.95]

Dermavant Sciences submits an NDA for tapinarof for treating mild, moderate and severe plaque psoriasis in adult patients.

Appeals Court Backs FDA in Stem Cell Case

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An 11th Circuit Appeals Court panel upholds a Florida district court decision in favor of FDA in a suit against US Stem Cell Clini...

Stop Implanting Medtronic HVAD System: FDA

[ Price : $8.95]

FDA says healthcare providers should no longer implant the Medtronic Heartware Ventricular Assist Device system that the company i...

Guide on Enteral Feeding Drug Testing/Labeling

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FDA posts a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recomm...

Liquidia NDA Resubmission Accepted for Review

[ Price : $8.95]

FDA accepts for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hyperte...

Greater FDA Oversight of SCRI Products Needed, Pew Says

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A Pew Charitable Trusts report details adverse events reported by patients using unapproved stem cell and regenerative medicine in...

Court Finds Zofran Suit Preempted by Federal Law

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The Massachusetts federal court grants summary judgment to GlaxoSmithKline and dismisses as preempted a suit claiming the company ...

CDRH ASCA Pilot on Schedule, Expecting Submissions

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CDRH ASCA team member Angela DeMarco says the ASCA pilot program is on schedule with 53 test labs accredited.