FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients to begin treatment ...
FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic cortico...
The House Energy and Commerce Subcommittee on Health plans a hearing 7/15 to examine how FDA can help strengthen U.S. leadership in biomedical innovat...
The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors developing over-the-...
FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing fa...
FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoceranib for first-line...
FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted temporarily while the a...
FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the therapy to be administe...
