FDA accepts for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus lower respiratory tract disease in newborns and in...
FDA publishes three Federal Register notices on device classifications related to de novo requests.
FDA says Lupin recalled one lot of 20 mg Quinapril tablets and three lots of 40 mg tablets due to the potential presence of N-Nitroso-Quinapril, a nit...
FDA approves the first injectable pentosan product for use in horses with osteoarthritis.
Washington Legal Foundation asks the Supreme Court to reverse a California appeals court decision that hit Ethicon with $300 million in civil penaltie...
FDA gives accelerated approval to Genentechs Lunsumio to treat some forms of follicular lymphoma.
FDA approves Gileads Sunlenca, the first in a new class of drugs to treat some HIV-1 patients.
FDA publishes a technical conformance guide for its guidance on the format and content of a REMS document.
