FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Clears Tenon Medical Expanded Use

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Vent Creativity Surgical Planning Software Cleared

[ Price : $8.95]

FDA clears a Vent Creativity 510(k) for its AI-driven software product, Hermes Knee, for generating surgical plans for mechanical,...

Immunovant Delays Seeking Approval of Batoclimab

[ Price : $8.95]

Immunovant delays its decision on whether to seek batoclimabs approval for treating myasthenia gravis and chronic inflammatory dem...

Uncertainty Rules at FDA: Henry Miller

[ Price : $8.95]

Former FDAer Henry Miller says uncertainty rules as FDA awaits the expected confirmation of Martin Makary as commissioner.

Calyxo Updates CVAC Aspiration Instructions

[ Price : $8.95]

An FDA medical device early alert says Calyxo has issued updated instructions for using its CVAC Aspiration Systems due to its ide...