ConsumerAffairs2h
Mountjaro, Zepbound removed from FDA's shortage list
The FDA has removed two of Eli Lilly's in-demand weight-loss and diabetes drugs from its shortage list. Diabetes drug ...
ENDPOINTS NEWS3h
FDA's drug cen­ter launch­es new co­or­di­nat­ing body for mod­el­ing and sim­u­la­tion
The FDA's Center for Drug Evaluation and Research on Wednesday officially launched a new center of excellence to better ...
Monthly Prescribing Reference1h
FDA Designates SGK1 Inhibitor Orphan Drug for Long QT Syndrome
The Food and Drug Administration (FDA) has granted Orphan Drug designation to LQT-1213, a first-in-class serum glucocorticoid regulated kinase 1 (SGK1) inhibitor, for the treatment of long QT syndrome ...
Lexington biotech resubmits dry eye drug for FDA approval a year after rejection
Lexington biotech Aldeyra is trying once again to win approval for its dry eye disease drug, called reproxalap, after an FDA ...
Becker's Spine Review39m
Spinal bone regeneration biologic earns FDA breakthrough device designation
Amphix Bio earned FDA breakthrough device designation for a bone regeneration drug-device combination, according to an Oct. 3 news release.
FDA issues recalls on at least 16 food and drug items in September. Here's a list
The FDA has removed the following items from store shelves this September, including pet food, baby powder and Lactaid.
Guacamole Recall Update as FDA Sets Highest Risk Level
The guacamole, peppers, and vegetables voluntarily recalled by the maker have been classed as the highest risk level by the ...
Cure Today6h
FDA Grants Priority Review to Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody-drug conjugate will be reviewed for the potential treatment of previously treated, unresectable or metastatic ...