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FDA Accepts Rockets Gene Therapy BLA Resubmission

[ Price : $8.95]

FDA accepts for review a Rocket Pharmaceuticals BLA resubmission for Kresladi (marnetegragene autotemcel), a gene therapy for seve...

Uzedy Expanded to Include Bipolar I Maintenance

[ Price : $8.95]

FDA approves an expanded indication for Teva and Medincells Uzedy (risperidone) to permit its use as monotherapy or adjunctive the...

Tvardis Lung Disease Drug Falls Short in Trial

[ Price : $8.95]

Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary...

Regeneron Gene Therapy Improved Rare Hearing Loss

[ Price : $8.95]

Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all childr...

Review Extended on Denalis Hunter Syndrome Drug

[ Price : $8.95]

FDA extends by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for Hunter syndro...

Medtronics Endurant Gains Expanded Indication

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FDA approves an expanded indication for Medtronics Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneury...

FDA Awards Breakthrough Status to Lymphoma Drug

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FDA grants BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refr...

Troubled Novo Nordisk Facility Gets OAI Status

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FDA assigns an Official Action Indicated classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomin...

FDA Approves Celltrions Eylea Biosimilar

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FDA approves Celltrions Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayers blockbuster Eylea for treating...