MHRA updates guidance for semaglutide prescribers and patients
MHRA updates product information regarding the very rare risk of non-arteritic anterior ischemic optic neuropathy (NAION) in patients taking semaglutide.
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Public advised to stop using some non-sterile alcohol-free wipes
UKHSA and MHRA are urging the public not to use 4 specified non-sterile alcohol-free wipe products due to the risk of infection associated with their use.
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FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cel -
Drug Trials Snapshots: REDEMPLO
Drug Trials Snapshots: REDEMPLO -
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. -
Drug Trials Snapshots: LEROCHOL
Drug Trials Snapshots: LEROCHOL -
Stay Informed about Small Business
Stay Informed about Small Business -
Glucose Monitor Sensor Recall: Abott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings -
FDA to Compounders: Know Your Bulks and Excipients Suppliers
FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active pharmaceutical ingredients (APIs), used to compound drugs. The agency urges compounders to know your bulks supplier and know if they are testing the drugs before you purchase bu -
Class 3 Medicines Recall: Aspar Pharmaceuticals Ltd, Ibuprofen 200mg Tablets, Ibucalm 200mg tablets, EL(26)A/07
Aspar Pharmaceuticals Ltd is recalling specific batches distributed in Aspar, Almus and Numark livery. The batches are being recalled as a precautionary measure following findings of foil perforations in some blisters.
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Early Alert: Heart Pump Issue from Abiomed
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift. -
Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.