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 ...
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 ...
ophthalmologytimes20m
Aldeyra Therapeutics resubmits New Drug Application for reproxalap for the treatment of dry eye disease
Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for topical ...
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.
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.
FDA Approves groundbreaking drug for schizophrenia treatment
On Thursday, the U.S. Food and Drug Administration (FDA) approved the drug Cobenfy which targets schizophrenia in a new way.
FDA Approves the First New Schizophrenia Drug in Decades
No new treatments for schizophrenia have been approved in nearly three decades, but that changed on Sept. 26, when the U.S.
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 ...
Monthly Prescribing Reference17h
FDA Drug Approval Decisions Expected in November 2024
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug ...
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 ...