FDA
Filling the Gaps in Surface Cleaning and Disinfection
It’s time to write or update the policies and procedures for cleaning and disinfection in your cleanroom ...
AUGUST 22, 2025
Vanrafia Receives Accelerated Approval
The FDA granted accelerated approval to Vanrafia for proteinuria reduction in primary immunoglobulin A nephropathy.
APRIL 24, 2025
Why Visibility Into DSCSA Readiness Data Is Key to Compliance
When the FDA announced it wouldn’t fully enforce the Drug Supply Chain Security Act in 2024, opting instead ...
APRIL 14, 2025
FDA Approves First Interchangeable Omalizumab Biosimilar
The FDA announced it has approved a biosimilar version of omalizumab. The drug, which will be marketed as Omlyclo ...
MARCH 7, 2025
First Treatment for Cerebrotendinous Xanthomatosis Approved
The FDA approved Ctexli for the lipid storage disease cerebrotendinous xanthomatosis in adults.
FEBRUARY 24, 2025
FDA Issues Alert About Smartphone-Compatible Diabetes Devices
The FDA issued a communication regarding difficulties with critical safety alerts intended to be delivered via ...
FEBRUARY 6, 2025
FDA Alert Highlights Smart Pump Software Anomalies
The FDA posted an alert noting that Fresenius Kabi USA has issued a letter to healthcare providers regarding a ...
JANUARY 21, 2025
Compounded GLP-1s Require Extra Vigilance
The FDA has issued several warnings in 2024 to healthcare providers and patients about the risks of obtaining GLP-1 ...
DECEMBER 18, 2024
Breathing New Life Into the Lung Cancer Pipeline
The next two years may well see an explosion of FDA approvals for non-small cell lung cancer, with some of the ...
DECEMBER 15, 2024
Strategies for Acing an FDA Inspection
Pharmacists tasked with choosing manufacturing partners for generic medications, outsourced compounded medications ...
DECEMBER 14, 2024
GLP-1 ‘Shadow System’ Of Internet Sellers Poses A Major Safety Concern
Dozens of unscrupulous web-based sellers of glucagon-like peptide-1 agonists are evading FDA scrutiny and patient ...
DECEMBER 13, 2024
After Helene Damage, FDA Grants Compounding Flexibility for IV Solutions During Shortage
With shortages of IV fluids expected to persist for an undetermined length of time due to the severe damage caused ...
OCTOBER 24, 2024
