FDA Updates

On September 20, 2021, the FDA announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

This section provides a brief overview of new cancer drugs and new indications approved by the FDA between June 30, 2021, and July 26, 2021.

This section provides a brief overview of new cancer drugs and new indications approved by the FDA between May 5, 2021, and May 28, 2021.

This section provides a brief overview of new cancer drugs and new indications approved by the FDA between April 13, 2021, and April 23, 2021.

This section provides a brief overview of new cancer drugs and indications approved by the FDA between February 5, 2021, and February 22, 2021.

This section provides a brief overview of new cancer drugs approved by the FDA between November 25, 2020, and December 18, 2020.

On September 4, 2020, the FDA accelerated the approval of pralsetinib (Gavreto; Blueprint Medicines/Genentech), an oral RET inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and RET-activating fusions, as detected by an FDA-approved test.

This section provides a brief overview of new cancer drugs approved by the FDA between July 31, 2020, and September 4, 2020.

This section provides a brief overview of new cancer drugs or new indications approved by the FDA between June 30, 2020, and July 24, 2020.

This section provides a brief overview of new cancer drugs or new indications approved by the FDA between May 26 and June 15, 2020.