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GE Healthcare Gets AIR Recon Imaging Clearance

[ Price : $8.95]

FDA clears a GE Healthcare 510(k) clearance for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic re...

BioMarin Refiles BLA for Hemophilia Gene Therapy

[ Price : $8.95]

BioMarin refiles its BLA for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A.

LivaNova Recall of Blood Pump Controller

[ Price : $8.95]

LivaNova (TandemLife) recalls its LifeSPARC Controller, part of the LifeSPARC blood pump system, due to a software malfunction.

User Fee Reauthorization Signed Into Law

[ Price : $8.95]

A bill, which was attached to a continuing resolution, reauthorizing FDAs user fee programs is signed into law by President Biden....

1/3 Accelerated Drugs Have Incomplete Confirmatory Trials

[ Price : $8.95]

An HHS Inspector General data snapshot finds that more than one-third of accelerated drug approvals have delinquent confirmatory t...

Clinical Decision Software Guide Expands Oversight: Attorneys

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Attorneys from DLA Piper complain that a new final FDA guidance on Clinical Decision Support (CDS) Software appears to be more exp...

Eugia Recalls 1 Lot of Acyclovir Sodium Injection

[ Price : $8.95]

Eugia U.S. (formerly AuroMedics Pharma) recalls one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a ...

Senate OKs Bill Ending Animal Testing Mandates

[ Price : $8.95]

The Senate unanimously approves legislation to end an FDA mandate for animal testing of experimental drugs before they can be used...

Medtronics Hemostasis Agent Cleared for Upper GI

[ Price : $8.95]

FDA clears a Medtronic 510(k) for its Nexpowder endoscopic hemostasis system.

Amylyx Lou Gehrigs Disease Drug Approved

[ Price : $8.95]

FDA approves Amylyxs amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate a...