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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

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

Trump Stalls Action on e-Cigarettes/Vaping

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President Donald Trump pulls back administration plans to issue new rules on e-cigarettes/vaping to curb youth access, reportedly ...

25th Approved Biosimilar Goes to Pfizers Abrilada

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FDA hits a milestone with the approval of Pfizers Abrilada (adalimumab - afzb), a biosimilar to AbbVies Humira, which is the 25th ...

FDA Hits Nascent Biotech on Drug Promotion

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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2 Fentanyl Transdermal Systems Withdrawn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...