AbbVie files a BLA supplement for Skyrizi (risankizumab-rzaa) for treating patients 16 years and older with moderate to severe Crohns disease.
FDA Review posts the Federal Register notices for the week ending 9/17/2021.
FDA Review posts product approval summaries for the week ending 2/7/2020.
FDA approves a Neovasc IDE for its COSIRA-II IDE clinical trial that will evaluate the Reducer device and its use in treating certain patients with re...
An FDA advisory committee unanimously votes to recommend Pfizer-BioNTechs Comirnaty Covid-19 booster vaccine in individuals 65 years of age and older ...
Federal Register notice: FDA makes available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act.
Pfizer expands its Chantix (varenicline) recall to include all lots of 0.5 mg and 1 mg tablets because of the potential presence of unacceptable N-nit...