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...
FDA approves a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to severely active Crohns di...
FDA clears a Vent Creativity 510(k) for its AI-driven software product, Hermes Knee, for generating surgical plans for mechanical, kinematic, and anat...
Immunovant delays its decision on whether to seek batoclimabs approval for treating myasthenia gravis and chronic inflammatory demyelinating polyneuro...
Former FDAer Henry Miller says uncertainty rules as FDA awaits the expected confirmation of Martin Makary as commissioner.
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...
FDA says the Baxter 2/5 recall of specific Spectrum infusion pumps was Class 1.
FDA publishes the FY 2025 OTC monograph drug facility fee and contract manufacturing organization fees.
