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Medtronic Expanded MRI Labeling for InterStim Devices

[ Price : $8.95]

FDA approves expanded MRI labeling for Medtronics InterStim II and InterStim Micro sacral neuromodulation systems that use SureSca...

2 Padcev sBLAs Submitted to FDA

[ Price : $8.95]

Astellas and Seagen file sBLAs with FDA to change Padcev to regular approval and expand its indication.

Comments Sought on WHO Drug Scheduling Recommendations

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Federal Register notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufactur...

FDA Facilitating Efforts to Coordinate Regenerative Medicine Therapy Standards

[ Price : $8.95]

FDA updates its efforts to coordinate the development of standards for regenerative medicine therapies as required by the 21st Cen...

Panel Votes Down BDs Lutonix Balloon PTA Catheter

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An FDA advisory committee votes not to recommend approval of BDs Lutonix drug-coated balloon PTA (percutaneous transluminal angiop...

Amgen NDA Gets Priority Review for Lung Cancer

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FDA accepts for priority review an Amgen NDA for sotorasib for treating certain patients with KRAS G12C-mutated locally advanced o...

Woodcock Rejects Public Citizen Firewall Proposal

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FDA acting commissioner Janet Woodcock defends the integrity of the agencys drug review processes and rejects a Public Citizen pro...

Amgen NDA Gets Priority Review for Lung Cancer

[ Price : $8.95]

FDA accepts for priority review an Amgen NDA for sotorasib for treating certain patients with KRAS G12C-mutated locally advanced o...

Verrica Pharma Resubmits NDA for Molluscum Drug

[ Price : $8.95]

Verrica Pharmaceuticals resubmits its NDA for VP-102 (cantharidin 0.7% topical solution), a proprietary topical therapy for treati...

FDA OKs Axonics Implantable Neurostimulator PMA

[ Price : $8.95]

FDA approves an Axonics Modulation Technologies PMA for its third-generation implantable neurostimulator.