FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing facilities and clarifying registration obligations for certain foreign drug manufacturers.
FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoceranib for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distributed manufacturing facilities and clarifying registration obligations for certain foreign drug manufacturers.
FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoceranib for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted temporarily while the agency reviewed legal and policy concerns surrounding its controversial transparency initiative.
FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the therapy to be administered using an on-body injector across all currently approved U.S. indications.
