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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

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

Calyxo Updates CVAC Aspiration Instructions

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

Baxter Spectrum Pump Recall is Class 1

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FDA says the Baxter 2/5 recall of specific Spectrum infusion pumps was Class 1.

FY 25 OTC Monograph Facility Fees Set

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FDA publishes the FY 2025 OTC monograph drug facility fee and contract manufacturing organization fees.

Complete Response on Lumbar Disc Herniation BLA

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FDA sends Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar...

FDA Delays Decision on Breast Cryoblation Device

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FDA delays its decision on an IceCure Medical de novo marketing authorization request for the ProSense cryoblation device and its ...