FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors with the agency's mos...
FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients to begin treatment ...
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...
An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firms laboratory controls, including a f...
