Biologics
FDA Extends Skyrizi sBLA Review by 3 Months
FDA extends by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohns disease.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/25/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/25/2022.
Human Drugs
FDA Revises AstraZenecas Evusheld Dosing
FDA revises an AstraZeneca emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to increase the initial dose for Covid-1...
Federal Register
FDA Amends Animal Drug Regs for Approvals
Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for applications made during 7/2021, 8/2021 and...
Federal Register
FDA Withdrawing 5 No-Longer-Marketed ANDAs
Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants after they notified the agency that the drug products are no lo...
Biologics
Pfizer sBLA for Interchangeable Humira Biosimilar
FDA accepts for review a Pfizer supplemental BLA for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Abbotts Humira.
Biologics
Smart Surgical Gets Warning Letter on BioBurst Products
FDA sends Boise, ID-based Smart Surgical, dba Burst Biologics, a Warning Letter after an inspection last year determined it is marketing unapproved pr...
Medical Devices
Teleflex Expanded Indication for Catheters/Guidewires
FDA clears a Teleflex expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous...
