Nasdaq

Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed Relapsed and/or Refractory Multiple Myeloma

U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023 European Medicines Agency has validated ...
Nasdaq

Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and ...

Applications based on results from TRANSCEND FL and TRANSCEND NHL 001, in which Breyanzi demonstrated clinically meaningful benefit with deep and durable responses Multiple regulatory applications ...
Business Wire

Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse ...

Additionally, Genmab announced that AbbVie (NYSE: ABBV) submitted a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large ...
FierceBiotech

Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymp

WESTMINSTER, Colo.--(BUSINESS WIRE)--Mar. 25, 2009-- Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ...
Seeking Alpha

Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for ...

Breyanzi has the potential to be the first and only CAR T cell therapy approved for MZL, addressing a high unmet need Application based on results from MZL cohort of TRANSCEND FL presented at ICML in ...