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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...[ Price : $8.95]
FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembro...[ Price : $8.95]
FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.[ Price : $8.95]
Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.