Each episode of this journey through a disease state contains both a physician guide and a downloadable/printable patient ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

The approval clears Enhertu for treating ... Drugmakers combine a chemotherapy drug with a monoclonal antibody designed to recognize and bind to a specific protein found on cancer cells.

The theory behind leucovorin's use for autism postulates that some children have a blockage in the transport of folic acid into the brain that potentially contributes to neurological symptoms.

More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green ...

After the US Food and Drug Administration approval in 2002 of the first ever ... I dedicated to make antibodies as human as possible, I am really happy to see that the market has finally ...

With over 80 publications, Mohta has expertise in the use of biological drugs for both cutaneous ... source of identical monoclonal antibodies. 2 Since 1986, over 117 monoclonal antibodies have been ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

Their approval and use in the USA and Europe will require review, but the extent of these reviews are still uncertain. New monoclonal antibodies directed against new targets are under development ...