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FDA General

Advisory Panel Conflicts of Interest Low: Study

A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS secretary Robert F. Ke...

Medical Devices

Tandem Recalls Insulin Pumps Due to Alarm Error

Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger...

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Human Drugs

Workshop on Patient Experience Data in Drug Development

FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug development and regulato...

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Human Drugs

Wegovoy OKd for Metabolic Steatohepatitis

FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associated steatohepatitis.

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Human Drugs

FDA OKs Tonix Drug for Fibromyalgia

Tonix Pharmaceuticals gains approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treating fibromyalgia in a...

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Human Drugs

FDA Delays Clinical Hold Review on Neurizon ALS Drug

Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics NUZ-001 and its use f...

Medical Devices

FDA Alert on Baxter Novum Infusion Pumps

FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that ...

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Biologics

Omeros BLA for Narsoplimab Gets Review Extension

FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microa...

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Human Drugs

FDA OKs Papzimeos for Respiratory Papillomatosis

FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenoviral vector-based immunotherapy for treating adult pat...

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Medical Devices

Alert on Medtronic DLP Left Heart Vent Catheters

FDA issues an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be...