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 ...
Lilly's weight-loss drug removed from FDA's shortage list
The U.S. Food and Drug Administration removed Eli Lilly's blockbuster weight-loss and diabetes drugs from its shortage list ...
US FDA says Lilly's weight-loss drug no longer in shortage
Eli Lilly's weight-loss drug Zepbound and diabetes drug Mounjaro are no longer in shortage, the U.S. Food and Drug ...
FDA makes end of Zepbound, Mounjaro shortage official
Removal of Lilly’s in-demand drugs from the FDA’s shortage list ramps up pressure on the companies selling compounded ...
Cure Today1h
FDA Approves Presurgical, Postsurgical Opdivo for NSCLC
The Food and Drug Administration has approved Opdivo before and after surgery for some with non-small cell lung cancer.
Cure Today2h
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 ...
BioSpace5h
Lilly’s Tirzepatide No Longer on FDA Drug Shortage List
BMO Capital Markets analyst Evan Seigerman called it “another positive indication” for Eli Lilly, which is growing market ...
Targeted Oncology2h
Acalabrutinib Receives FDA Priority Review in Frontline MCL
Acalabrutinib, a BTK inhibitor, has shown promising results in treating mantle cell lymphoma, with the FDA granting it ...
Eat first, test later: How the FDA’s food regulatory system is broken
A regulatory loophole allows manufacturers to add untested ingredients to food that are later found to be dangerous. Here’s ...
Lilly weight-loss drug copycats dealt blow as shortage ends
Eli Lilly & Co.’s blockbuster weight-loss and diabetes drugs are no longer considered to be in shortage in the U.S., ...
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 ...
Eli Lilly’s weight-loss and diabetes drugs are no longer in shortage, says FDA
The U.S. Food and Drug Administration said Eli Lilly’s diabetes and weight-loss drugs marketed as Zepbound and Mounjaro are ...