We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

I Agree

You are here: Industry Insights > DARZALEX FASPRO

News List

FDA Grants Accelerated Approval to Darzalex Faspro for Newly Diagnosed Light Chain Amyloidosis americanpharmaceuticalreview
January 27, 2021
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) ...
Janssen Submits Light Chain Amyloidosis Treatment to FDA americanpharmaceuticalreview
September 17, 2020
Halozyme Therapeutics announced its collaborator Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) ...
Janssen Receives FDA Approval of DARZALEX FASPRO with ENHANZE for Multiple Myeloma americanpharmaceuticalreview
May 07, 2020
Halozyme Therapeutics announced its collaborator Janssen Biotech has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj).