Maci®

MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in...

Rethymic®

RETHYMIC (allogeneic processed thymus tissue-agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia.

Yescarta®

YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months...

Lenmeldy

LENMELDY (atidarsagene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ)...

Bravelle®

BRAVELLE (urofollitropin) is a gonadotropin indicated for: Induction of ovulation in women who have previously received pituitary suppression – intramuscular and subcutaneous administration; Development of multiple follicles as part of an Assisted Reproductive...

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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