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