On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of
Similar Posts
PureRawz – 715218 – 09/08/2025
Unapproved New Drugs/MisbrandedSanofi S.p.A. – 05/22/2023
Sanofi S.p.A. – 05/22/2023. Country: Italy. Record Type: 483African Food on Wheels Inc. Recalls Oven Dried Fish (Scomberomorus Cavalla) Because of Possible Health Risk
African Food on Wheels Inc. of Bronx, NY is recalling 28 boxes of Product, because it is a dried, un-eviscerated (internal organs not removed) fish greater than 5 inches and length and has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illneMonoclonal Antibodies: Streamlined Nonclinical Safety Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”About CDER Small Business and Industry Assistance (SBIA)
CDER Small Business and Industry Assistance (SBIA) helps small pharmaceutical business and industry navigate the wealth of information that FDA offers, and provides assistance in understanding the regulation of human drug products.BsUFA III: Fiscal Years 2023-2027
New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.
