Medical Devices
Cardiovascular Systems Recall Wirion Device
Cardiovascular Systems recalls its Wirion system due to complaints about filter breakage during retrieval.
Human Drugs
Fast Track for Retinal Therapy
FDA grants 4D Molecular Therapeutics a fast track designation for 4D-125 for treating patients with inherited retinal dystrophies due to defects in th...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 1/7/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/7/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Court Rules Against FDA in Vaccine FOIA Request
A Texas federal court rules against FDA in a Freedom of Information Act lawsuit by a group seeking data and information on the Pfizer/BioNTech Covid-1...
Human Drugs
Moderna Booster Shot Shortened to 5 Months
FDA amends the emergency use authorization for the Moderna Covid-19 vaccine to shorten the time between the completion of primary vaccination with the...
Human Drugs
AbbVie sNDA for Rinvoq in Axial Spondyloarthritis
AbbVie files a supplemental NDA for Rinvoq (upadacitinib,15 mg once daily) for treating certain adults with active non-radiographic axial spondyloarth...
Human Drugs
PhRMA Study Finds 50% of Drug Pricing Goes to Middlemen, Others
A PhRMA-funded study finds that more than half of every $1 spent on brand medicines went to payers, middlemen, providers, and other stakeholders in 20...
Medical Devices
BD Bacterial Identification Testing System Cleared
FDA clears a Becton, Dickinson 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiology bacterial identifi...
