[ Price : $8.95]
FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors w...[ Price : $8.95]
FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients...[ Price : $8.95]
The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors ...[ Price : $8.95]
FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distribu...[ Price : $8.95]
FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoce...[ Price : $8.95]
FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted tem...[ Price : $8.95]
FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the the...[ Price : $8.95]
An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firms laboratory con...