USA – FDA approves first treatment for adults with complement 3 glomerulopathy, a rare...
The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria.
Fabhalta is...
USA – FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting
After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine,...
USA – Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials
Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand...
Canada – Submitting risk management plans guidance document: Overview
This guidance document on submitting risk management plans, published on February 24, 2025, will come into effect on July 1, 2025.
In the meantime the Guidance...
USA – FDA alerts drug manufacturers to the risk of benzene contamination in certain...
FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug...
USA – FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and...
USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
USA – FDA approves new Alzheimer’s treatment regimen
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once every four weeks intravenous (IV) maintenance...
USA – CDER announces new guidance agenda for 2025
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance...
USA – FDA draft guidance outlines appropriate use of tissue biopsies in clinical trials
When are tissue biopsies really needed in clinical trials of medical products? Draft guidance from the US Food and Drug Administration (FDA) offers recommendations...
