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Safety Alert on Hologics BioZorb Markers

[ Price : $8.95]

FDA issues a safety alert recommending that healthcare providers not use BioZorb Markers and BioZorb LP Markers manufactured by Ho...

Iterum Therapeutics Antibiotic OKd for UTIs

[ Price : $8.95]

FDA approves an Iterum Therapeutics NDA for Orlynvah (sulopenem etzadroxil and probenecid) for treating certain uncomplicated urin...

Orphan Status for Sickle Cell Disease Drug

[ Price : $8.95]

FDA grants Kind Pharmaceutical an orphan drug designation for AND017 and its use in treating sickle cell disease.

Smiths Medical Recalls Tracheostomy Products

[ Price : $8.95]

Smiths Medical recalls specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect.

Support for Biosimilar Product Class Guidances

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PhRMA and USP recommend that FDA develop product class-specific guidances rather than product-specific guidances to spur the devel...

Panel To Discuss 503A Bulk Drug Additions

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Federal Register notice: FDA announces a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substan...

Intellia Reports Positive Data on Gene Therapy

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Intellia Therapeutics reports positive data from the ongoing Phase 1/2 study of NTLA-2002, a CRISPR-based gene editing therapy, in...

Probe Leqembi, Kisunla Trials: Public Citizen

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The Public Citizen Health Research Group calls for a federal investigation into clinical trials for two Alzheimers drugs that may ...

Baxter Class 1 Recall of Life2000 Ventilator

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Baxter Healthcare recalls (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail ...

Pfizers Changes to Total Lifecycle Patient Preference Guide

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Pfizer submits pages of recommended changes to an FDA draft guidance on incorporating voluntary patient preference information ove...