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FDA Accepts Samsung BLA for Avastin Biosimilar

[ Price : $8.95]

FDA accepts for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).

Safety Update on Maquet/Datascope Pumps

[ Price : $8.95]

An FDA device safety update says more adverse event reports have been received about intra-aortic balloon pumps by Getinges Maquet...

FDA Hits Nascent Biotech on Drug Promotion

[ Price : $8.95]

FDA sends Nascent Biotech an untitled letter objecting to promotional content on the companys Web site about its investigational d...

Final Smallpox Drug Development Guide Posted

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FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.

2 Fentanyl Transdermal Systems Withdrawn

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Federal Register notice: FDA withdraws ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis ...

Panel Recommends Against Mercury-containing Amalgam

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FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away f...

Cerapedics PMA Supplement OKd for Bone Graft

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FDA approves a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion proce...

CDRH Patient and Caregiver Connection Program

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CDRH sets up a Patient and Caregiver Connection program to obtain feedback from these stakeholders on their experiences living wit...

Contact Lens for Pediatric Myopia Slowing Approved

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FDA approves CooperVisions MiSight, the first contact lens indicated to slow the progression of myopia in children between the age...

Levo Therapeutics Fast Track for Prader-Willi Drug

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FDA grants Levo Therapeutics a fast track designation for LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome.