FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Objectionable Conditions at BTS Research

[ Price : $8.95]

FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinica...

X4 Pharma NDA Accepted for WHIM Syndrome

[ Price : $8.95]

FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older ...

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

[ Price : $8.95]

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

Asensus Surgical Recalls Surgical System

[ Price : $8.95]

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

17 Drugs Not Withdrawn Over Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that 17 listed drug products were not withdrawn from sale for safety or efficacy reasons.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

[ Price : $8.95]

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

Multiple Violations at WAVi Co.

[ Price : $8.95]

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

[ Price : $8.95]

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

Clinical Hold Lifted on Mersanas XMT-2056

[ Price : $8.95]

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