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Winrevair Study Stopped on Positive Data: Merck

[ Price : $8.95]

Merck stops early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension ...

Neurogene Gene Therapy Patient Dies After Dosing

[ Price : $8.95]

Neurogene says a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died.

Endo Recalls Clonazepam Due to Mislabeling

[ Price : $8.95]

Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.

FDA Research Links Montelukast to Mental Issues

[ Price : $8.95]

FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental...

Counterfeit Batteries Leads to Infusion Pump Recall

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ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devic...

Jazz Biliary Tract Cancer BLA Approved

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FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metasta...

2 Orthopedic Non-Spinal Bone Guidances Posted

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FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.

Philips Radiology Remote Scanning Features Cleared

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FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Comm...

Guide on 510(k) Third-Party Reviews

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Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program and Third-Party Emergency...

CDRH New Pilot on High-Risk Recalls

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CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by compa...