FDA Related News

Medical Devices

FDA Clears Tenon Medical Expanded Use

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

Medical Devices

Bard Recalls Rotarex Atherectomy Device Instructions

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

Human Drugs

FDA Again Delays Non-Rx Drug Final Rule

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

Human Drugs

Liver Cancer Combo Gets 2nd Complete Response Letter

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

FDA General

Former FDA Deputy Bumpus Lands at Recursion

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

Biologics

Tremfya Approved for Crohns Disease

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

Medical Devices

Vent Creativity Surgical Planning Software Cleared

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

Human Drugs

Immunovant Delays Seeking Approval of Batoclimab

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

Uncertainty Rules at FDA: Henry Miller

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

Medical Devices

Calyxo Updates CVAC Aspiration Instructions

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