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 ...
Monthly Prescribing Reference15h
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 ...
Cure Today24m
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 ...
Targeted Oncology24m
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 ...
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.
STAT1d
After Cassava Alzheimer’s drug fiasco, the FDA must intervene to protect patients
The SEC concluded that Cassava Sciences falsified data in its Alzheimer’s clinical trials. Now the FDA needs to act, ...
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.
JD Supra20h
Ninth Circuit strengthens FDA authority to enforce drug regs against certain stem cell products
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell ...