NORTH CHICAGO, Ill. – AbbVie today announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson’s medicinal products have not given satisfactory results. PRODUODOPA is...
treatment News
NORTH CHICAGO, Ill. — AbbVie announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these...
NORTH CHICAGO, Ill. — AbbVie (NYSE: ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the...
NORTH CHICAGO, Ill. — AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering patients another VENCLEXTA combination regimen with the potential for time-limited...
NEWTON, Mass. — Abcuro, Inc., today announced topline results from the Phase 2/3 MUSCLE clinical study of ulviprubart (ABC008), an investigational monoclonal antibody in development for the treatment of patients with inclusion body myositis (IBM), a rare, debilitating and relentlessly progressive chronic autoimmune disease that currently has no approved treatment...
NEWTON, Mass. — Abcuro, Inc., a late-stage clinical biotechnology company developing potentially first-in-class immunotherapies designed to benefit people living with debilitating and progressive rare autoimmune diseases and for other indications where certain cytotoxic T cells are pathogenic, today presented interim data from the ongoing Phase 1/2 clinical trial evaluating ulviprubart...
NEWTON, Mass. — Abcuro, Inc., a clinical stage biotechnology company, today presented results at the 6th Global Conference on Myositis (GCOM) meeting, being held March 23-26, 2026 in Lisbon, Portugal from the Phase 2/3 MUSCLE clinical study of ulviprubart (ABC008), an investigational monoclonal antibody in development for the treatment of patients...
CLEVELAND, Ohio – Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing genetic medicines for serious diseases with high unmet need, today announced activation of the Children’s Hospital of Philadelphia (CHOP) as the sixth Qualified Treatment Center (QTC) for the administration of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. “Activation...
CLEVELAND, Ohio — Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the first commercial patient treatment with FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, autologous gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN was administered at Lucile Packard Children’s Hospital Stanford in Palo...
CLEVELAND, Ohio — Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot...
