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Medtronics Affera Mapping/Abalation Device Approved

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FDA approves Medtronics Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation.

Animal Drug Regs Amended to Reflect Approvals

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related...

Kinova Recalls Wheelchair Robotic Arm

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Kinova recalls (Class 1) its Jaco assistive robotic arm to correct the device due to an increased fire hazard.

Safety Alert on Hologics BioZorb Markers

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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

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

Orphan Status for Sickle Cell Disease Drug

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

Smiths Medical Recalls Tracheostomy Products

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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...