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Medtronic HeartWare Dear Doctor Letter

[ Price : $8.95]

A Medtronic Dear Doctor letter describes a potential issue with the driveline cover in its HeartWare Ventricular Assist Device.

Lillys Donanemab Tops Aduhelm in Study

[ Price : $8.95]

Lilly says its investigational Alzheimers drug donanemab outperformed Biogens Aduhelm in clearing brain amyloid in a Phase 3 compa...

Innoviva Files NDA for Sul-Dur Antibiotic

[ Price : $8.95]

FDA accepts for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections cause...

Argenx Buys Priority Review Voucher from Bluebird for $102 Mil.

[ Price : $8.95]

Argenx pruchases a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efg...

Act on Orphan Drug Exclusivity: Attorney

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Mayer Brown attorney George OBrien calls on FDA to take steps to respond to a 2021 11th Circuit Court of Appeals decision throwing...

Medical Device Recalls at Two-Year High: Sedgwick

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The Sedgwick second quarter recall index shows that medical device recalls hit a two-year high, while pharmaceutical recalls remai...

9 Observations in Qualgen FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with nine observations from an inspection at the Edmond, OK-based Qualgen outsourcing facility.

Enovis STAR Instrumentation for Ankle Replacement OKd

[ Price : $8.95]

FDA approves an Enovis PMA for the STAR Patient Specific Instrumentation and its use with the companys STAR total ankle replacemen...

HHS Delegates Authorities to FDA/NIH for ALS Partnership

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Federal Register notice: HHS delegates to FDA and NIH authorities under the Accelerating Access to Critical Therapies for ALS Act ...

Make UDI Publicly Available in Databases: Petition

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Ombu Enterprises petitions FDA to make unique device identifier information publicly available in the MAUDE and Recall databases.