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FDA OKs Gene Therapy Trial for Heart Disease

[ Price : $8.95]

FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-b...

AdvaMed Points ONCD to Cyber Harmonization

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AdvaMed tells the National Cyber Director about domestic and international efforts involving FDA to harmonize medical device cyber...

Asensus Surgical Recalls Surgical System

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Asensus Surgical recalls its Senhance Surgical System due to the potential for the devices to malfunction.

17 Drugs Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.

Amgens Interchangeable Stelara Biosimilar Approved

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FDA approves an Amgen BLA for Wezlana (ustekinumab-auub), an interchangeable biosimilar to Janssens Stelara for multiple inflammat...

Multiple Violations at WAVi Co.

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FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unappr...

Stakeholders Views on FRAME

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FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.

Clinical Hold Lifted on Mersanas XMT-2056

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FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynth...

Sage Huntingtons Drug Gets Orphan Status

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FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.

Regulatory Review Period for Omegaven

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (f...