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Sarepta Sells Priority Voucher for $102 Million

[ Price : $8.95]

Sarepta Therapeutics sells for $102 million its Rare Pediatric Disease Priority Review Voucher that was awarded last month.

Hemogenyx CAR-T Therapy on Clinical Hold

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FDA issues Hemogenyx Pharmaceuticals a clinical hold on an IND for the companys chimeric antigen receptor T-cells therapy for trea...

Uniform AI/ML Marketing Guidelines Needed: Study

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New York University researchers say more study is needed to develop uniform marketing guidelines for software-heavy medical device...

VCN-01 Orphan Status for Pancreatic Cancer

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FDA grants Theriva Biologics an orphan drug designation for VCN-01, a systemic, selective, stroma-degrading oncolytic adenovirus f...

Madrigal Rolling NDA for Resmetirom

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Madrigal Pharmaceuticals begins a rolling NDA submission seeking accelerated approval of resmetirom for treating nonalcoholic stea...

Teleflex Recalls Endotracheal Tubes

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Teleflex recalls its Slick Set Uncuffed Endotracheal Tube and Stylet Set (oral/nasal) due to reports about the 15mm connector disc...

House Bill on Provisional Drug Approvals

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Bipartisan House members reintroduce the Promising Pathway Act that would provide a provisional approval pathway for promising dru...

Info Collection on New Animal Drugs

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Federal Register notice: FDA announces an information collection revision entitled New Animal Drugs for Minor Use and Minor Specie...

More Regulation Needed for Generics: Bloomberg

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A Bloomberg editorial calls for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutica...

Guide on Chronic Rhinosinusitis Drugs

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Federal Register notice: FDA makes available a final guidance entitled Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs ...