Drug Watch: Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis (September 2007) (PDF)

Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.

Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.

The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.

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.

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.

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.