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U.S. Food and Drug Administration (FDA)

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U.S. Food and Drug Administration (FDA) News

FDA gives priority status to PaxVax's cholera vaccine

The U.S. Food and Drug Administration (FDA) recently gave a priority review status to a Biologics License Application for filing and reviewing a single-dose oral cholera vaccine known as Vaxchora. Read More »

FDA approves flu drug for those 65 and older

Fluad, a seasonal flu drug that contains an adjuvant, has gained first-of-its-kind market approval from the Food and Drug Administration to be used by people who are over 65. Read More »

FilmArray Meningitis/Encephalitis Panel receives FDA clearance

BioMerieux, a global leader in vitro diagnostics, recently announced that its molecular biology affiliate, BioFire Diagnostics, has received a de novo clearance from the U.S. Food and Drug Administration (FDA) for the FilmArray Meningitis/Encephalitis (ME) Panel. Read More »

HHS unit sponsoring development of drug for severe flu cases

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is sponsoring a drug being developed to treat patients hospitalized with severe cases of influenza. the Biomedical Advanced Research and Development Authority (BARDA) said this week. Read More »

Ebola drug ZMapp gains fast-track status from the FDA

LeafBio Inc.,  the commercial arm of Mapp Biopharmaceutical Inc., recently announced that its ZMapp has gained fast-track status designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for Ebola. Read More »

Flu vaccine for elderly on track to approval

NVS Influenza Vaccines said Tuesday its candidate vaccine for those 65 and older to protect against seasonal influenza is currently under review by the U.S. Food and Drug Administration (FDA). Read More »

Vaxart works to advance oral tablet vaccines

Vaxart Inc. is creating a broad range of vaccines that are designed to be taken orally in tablet form rather than by a needle. Read More »

Clinical trials for H1N1 influenza vaccine show promise

Vaxart Inc., a clinical-stage, privately held company that creates vaccines that are given to patients in the form of tablets instead of injections, recently announced that it has received positive results from its Phase 1 clinical trial of its oral H1N1 influenza vaccine. Read More »

FDA approves new chronic hepatitis C genotype 3 infection treatment

The U.S. Food and Drug Administration (FDA) approved Daklinza, or declatasvir, to be used with sofosbuvir as treatments for hepatitis C virus (HCV) genotype 3 infections on Friday. Read More »

FDA announces 2014 Food Safety Challenge winners

The U.S. Food and Drug Administration (FDA) on Wednesday announced the 2014 FDA Food Safety Challenge winners in a competition to advance breakthrough ideas on detecting disease-causing organisms in food. Read More »

Sanofi Pasteur delivers first 2015-2016 seasonal flu vaccines in U.S.

Sanofi Pasteur, the Sanofi vaccine division, recently announced the first shipment of its original Fluzone influenza vaccine doses for the upcoming 2015 and 2016 influenza season in the U.S. Read More »

Researchers begin Phase II trial for diabetes reversing vaccine

Researchers from the Massachusetts General Hospital recently received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase II clinical trial to test a generic vaccine’s ability to reverse advanced Type 1 diabetes. Read More »

LabCorp shares 2 new hepatitis C virus drug resistance assays

HCV NS5A and NS5B join company's HCV GenoSure NS3/4A in battling hep C Read More »

Merck receives FDA Breakthrough Therapy designations for HCV treatment

Merck, commonly called MSD outside the US and Canada, recently announced that it has received Breakthrough Therapy designation from the United States Food and Drug Administration (FDA) for the company’s grazoprevir/elbasvir investigational single tablet regimen to treat chronic hepatitis C virus (HCV) infections. Read More »

European committee gives positive review to GARDASIL 9 HPV vaccine

New vaccine by Sanofi Pasteur MSD contains largest quantity of HPV types. Read More »

FDA approves Quadracel DTaP-IPV vaccine

Immunization protects children from poliomyelitis, pertussis, diphtheria and tetanus. Read More »

FDA launches first drug shortages app

App will provide faster access to updated drug information. Read More »

Top-line results positive for Pfizer's TRUMENBA Phase 2 study

Pfizer, Inc. on Tuesday announced positive top-line results from a phase two study of TRUMENBA, a meningococcal group B vaccine, administered with U.S. Read More »

Data suggest Cepheid Xpert MTB/RIF Assay improves TB tests

The FDA recently approved the Cepheid Xpert MTB/RIF Assay to help physicians determine whether patients with suspected tuberculosis can be removed from airborne infection isolation. Read More »

FDA names new deputy commissioner for medical products, tobacco

The Food and Drug Administration appointed Dr. Robert Califf on Monday as its deputy commissioner for medical products and tobacco. Read More »