It was reported yesterday the US Food and Drug Administration (USFDA) has granted approval Novartis' Sandoz unit for Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen's Neulasta (pegfilgrastim).
The product has been indicated to decrease the chance of infection caused by low white blood cell count with a fever, a condition called febrile neutropenia. The biosimilar has been approved for use in patients with non-myeloid malignancies who are undergoing treatment with myelosuppressive anti-cancer drugs known for causing febrile neutropenia incidents as side effects.
Sandoz is expected to launch Ziextenzo in the US before the end of the year.
Spinogenix to present SPG601 Phase 2a trial results at AACAP Conference
AnnJi Pharmaceutical secures FDA Fast Track Designation for AJ201 in rare neuromuscular disease
Myosin Therapeutics' MT-125 granted US FDA Fast Track designation in glioblastoma
Boehringer Ingelheim's JASCAYD (nerandomilast) IPF treatment gains Chinese regulatory approval
Galera Therapeutics sells dismutase mimetics portfolio to Biossil in USD108.5m agreement
Arcturus reports interim Phase 2 data for ARCT-032 in cystic fibrosis
Sanofi's efdoralprin alfa shows superior results in phase 2 study for AATD
FDA accepts Xspray Pharma's NDA for XS003 with PDUFA date set for June 2026
Citius Oncology and McKesson sign US distribution agreement for LYMPHIR
Cumberland Pharmaceuticals adds FDA-approved oral capsule for H. pylori to commercial portfolio
Genentech's Gazyva (obinutuzumab) receives US FDA approval to treat adults with lupus nephritis