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...
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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., 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...
NEW YORK and CLEVELAND – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the activation of a second clinical trial site in its pivotal Phase 3 VIITAL™ study of its investigational EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB) at UMass Memorial Medical Center...
NEW YORK and CLEVELAND – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, announced the appointment of two with significant biotechnology and life sciences experience: Faith L. Charles, Partner, Corporate Transactions and Securities at Thompson Hine LLP and Mark Alvino, President at life sciences strategic...
NEW YORK and CLEVELAND – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced its sponsorship of the second annual Venture Into Cures, a virtual event supporting EB Research Partnership’s mission to find a cure for epidermolysis bullosa (EB). The event will take place virtually...
NEW YORK and CLEVELAND – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Dr. Leila Alland and Mr. Donald Wuchterl as new independent members to its Board of Directors. “Leila and Donald bring a collective wealth of diverse biologics experience...
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...