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...
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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...
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...