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Julie Tierney Joins Leavitt Partners

[ Price : $8.95]

Former FDAer Julie Tierney is now a principal in Leavitt Partners Washington office.

J&J Complete Response Letter on Darzalex Faspro

[ Price : $8.95]

FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidas...

Instylla PMA Approved for Hypervascular Tumors

[ Price : $8.95]

FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in...

FDA Acting Against Unapproved Thyroid Meds

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FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medicat...

Lilly Plans NDA for Oral Weight-Loss Drug

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Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-an...

Alert on Boston Scientific Defibrillation Leads

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FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads tha...

FDA Early Alert on Watchman Devices

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FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use i...

Quarantine Some Medline ReNewal Catheters

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An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due t...

FDA Accelerated Approval for Jazz Modeyso

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FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

QS, MDR Issues at Taiwans Visgeneer

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FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood gluc...