The CDER Office of Prescription Drug Promotion says an Esperion TV spot for Nexlizet falsely claims it is the only FDA-approved drug to lower LDL chol...
A biopharmaceutical expert petitions FDA to establish a risk-based regulatory framework for peptide therapeutics.
At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using real-world evidence and calculating the 510(k) tim...
FDA releases the form FDA-483 with nine observations from an inspection at Greeces Pharmathen International.
FDA issues a complete response letter to Outlook Therapeutics seeking additional confirmatory evidence for its BLA for Lytenava to treat wet AMD.
FDA grants priority review for an Axsome Therapeutics sNDA to treat Alzheimers disease agitation.
Two lengthy news service stories raise questions about FDAs approach to vaccines being espoused by CDER director Tracy Beth Heg and CBER director Vina...
FDA issues a complete response letter to Sanofis NDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis in adults.
