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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...

FDA Again Delays Non-Rx Drug Final Rule

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FDA delays again a final rule entitled Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU) to...

Liver Cancer Combo Gets 2nd Complete Response Letter

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HLB and Chinas Antengene say FDA has issued a second complete response letter on rivoceranib and its use in combination with camre...

Former FDA Deputy Bumpus Lands at Recursion

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Former FDA principal deputy commissioner and second-in-command Namandj Bumpus joins the board of Recursion, a Tech/Bio company tha...

Tremfya Approved for Crohns Disease

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FDA approves a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to sever...