The US Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

The Food and Drug Administration issued a proposed rule that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices. Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the patient. This allows timely identification of TB disease. Currently, the...

FluMist Quadrivalent , a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved by the U.S. Food and Drug Administration.

In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns. Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold p...

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu ( oseltamivir phosphate) for oral suspension.