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Abiomed Impella Heart Pump Recall is Class 1

[ Price : $8.95]

FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.

Insulet Omnipod Pod Recall is Class 1: FDA

[ Price : $8.95]

FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.

FDA Selects 7 PreCheck Pilot Participants

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FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufac...

Next-Generation Sequencing Data Submission Guidance

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FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.

FDA OKs Blood Cancer Drug Tregzi

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FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers...

CGMP Issues at Indias Wizcure Pharmaa

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FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.

Chinese Drug Firm Refuses FDA Record Request

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FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter d...

CBER SOPP on Implementing, Managing REMS

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CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.

FDA Novel Drug Approvals Remain Steady in 2026 First Half

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FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consist...

Complete Response on Liver Imaging Agent

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FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.