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March 21, 2022
Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.
September 29, 2021
Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.
September 28, 2021
The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.
April 21, 2014
FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
April 16, 2014
FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.
April 02, 2013
In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.
September 14, 2009
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
September 01, 2007
Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis
Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.
A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.
