FDA Proposes Lower Risk Classification for Tuberculosis Testing
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...
FDA Recalls Balloon Catheter
Acclarent , Inc initiated a recall of their balloon catheter device designed to dilate and restore airflow to a patient's airways.
Climate Change Heating Up Respiratory Diseases
Mild winters and warmer weather year round may have some negative side effects. A new position paper believes that climate change will be responsible for even more respiratory disease cases.
Prevnar 13 Shown to be Immunogenic in Adolescents
Pfizer Inc. announced Prevnar 13 ( Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years.
Bone Disease and Enzyme-Replacement Therapy
A rare life-threatening bone disease that impairs breathing may soon be treatable. In a recent study, enzyme-replacement therapy was effective in improving lung function and motor skills.
Preemies Breathe Better With new Rx
Newborns who arrive early often face respiratory problems since their lungs may not yet be fully developed. A new drug approved by the FDA joins four others to treat these problems.
A Natural Killer That Can Help Flu Outbreak
Fear of a flu epidemic is a constant concern for scientists and researchers. A new study may help reduce those fears thanks to a “natural killer.”
Novel Vaccine to Prevent Seasonal Influenza Approved
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.
The Dream of a Universal Flu Vaccine
It's the medical breakthrough that disease experts have long dreamed about: A “universal” flu vaccine that would last for years and protect against all strains of flu virus.
Garlic Repels More Than Just Vampires
Despite long traditional use, there is limited data about the influence of garlic on cold and flu treatment. Recent clinical trials are illuminating how this plant keeps us healthy.