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Articles tagged with "fda"

FDA approves New Influenza Vaccine for Older People

Sanofi Pasteur announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone® High-Dose (Influenza Virus Vaccine). Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. This age group typically [...]

FDA approves Seasonal Influenza Vaccine Agriflu

On Friday, the U.S. Food and Drug Administration (FDA) approved Agriflu, a vaccine for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. Manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, Agriflu is administered as a single injection in the upper arm and is available in [...]

Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration (FDA) on Monday published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic manufacturers can submit a request to the FDA for an Emergency Use [...]

FDA approves Seasonal Influenza Vaccine for Children

(Assams.Info) - The U.S. Food and Drug Administration (FDA) on Monday approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.
The safety and effectiveness of [...]

US approves 2009 H1N1 Influenza Virus Vaccines

(Assams.Info) - The US Food and Drug Administration (FDA) approved four new swine flu vaccines on Tuesday. The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.
“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs [...]

FDA approves two new HPV tests

The Food and Drug Administration (FDA) of United States has approved the first genetic tests for two types of human papillomavirus (HPV) that cause the majority of cervical cancers.
The test Cervista HPV 16/18 screens for the DNA sequences of HPV types 16 and 18 in cervical cells, that cause about 70% of cervical cancer cases [...]

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