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Vaccine Studies Should Have Transmission Rate Data: Marks

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CBER director Peter Marks says vaccine clinical trial designs should evaluate the investigational vaccines effect on disease trans...

Breakthrough Status for AI Electrocardiogram

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FDA grants Powerful Medical a breakthrough device designation for its PMcardio STEMI artificial intelligence electrocardiogram mod...

Alnylam Gets Additional Approval for Amvuttra

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FDA approves an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin...

Fabhalta Approved for Rare Kidney Disease

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FDA approves a Novartis NDA for Fabhalta (iptacopan) for treating adults with C3 glomerulopathy to reduce proteinuria.

Abbott IDE OKd for Coronary Artery Blockages Trial

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FDA approves an Abbott IDE for a clinical trial to evaluate its investigational coronary intravascular lithotripsy system and its ...

New FDA Building Completed as DOGE Cuts 27 Others

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The government completes a construction project for a new 11,000 square feet FDA annex building in San Juan District as the Trump ...

No Panel Review for Tonix Pharma Fibromyalgia NDA

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FDA passes on holding an advisory committee meeting to review a Tonix Pharmaceuticals NDA for TNX-102 SL (cyclobenzaprine HCl subl...

Fast Track for Secretome Heart Failure Drug

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FDA awards Secretome Therapeutics a fast track designation for STM-01, the companys neonatal cardiac progenitor cell therapy for ...

FDA Clears Tenon Medical Expanded Use

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FDA clears a Tenon Medical 510(k) for an expanded indication for the Catamaran SI Joint Fusion System for use in augmenting thorac...

Bard Recalls Rotarex Atherectomy Device Instructions

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Bard Peripheral Vascular updates the instructions for use (Class 1 recall) for its Rotarex Atherectomy Systems after receiving rep...