FDA Related News

Biologics

FDA Accepts Samsung BLA for Avastin Biosimilar

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

Medical Devices

Safety Update on Maquet/Datascope Pumps

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

FDA General

Trump Stalls Action on e-Cigarettes/Vaping

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

Biologics

25th Approved Biosimilar Goes to Pfizers Abrilada

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

Human Drugs

Levo Therapeutics Fast Track for Prader-Willi Drug

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

FDA Hits Nascent Biotech on Drug Promotion

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

Human Drugs

Final Smallpox Drug Development Guide Posted

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

Federal Register

2 Fentanyl Transdermal Systems Withdrawn

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

Medical Devices

Panel Recommends Against Mercury-containing Amalgam

FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away from using mercury-co...

Medical Devices

Cerapedics PMA Supplement OKd for Bone Graft

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