FDA News

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA...

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), presented a new analysis today demonstrating that second-line Yescarta® (axicabtagene ciloleucel) therapy offers consistent benefits in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL), even among those ineligible for the previous standard of care, high-dose chemotherapy followed by an autologous stem cell transplant (ASCT). Results were shared from the combined analysis of four-year data from the la...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes compared to on-demand (OD) treatment with bypassing agents. HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection requiring minimal preparation and no tr...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced new positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma (RRMM). These data are being presented during an oral presentation at the 67th American Society o...

SOMERVILLE, Mass.--(BUSINESS WIRE)--Genetix Biotherapeutics Inc. today announced their participation in the American Society of Hematology’s (ASH) exclusive press program ahead of the 67th ASH annual meeting in Orlando, Florida (December 6-9, 2025). Genetix’s abstract Accelerating access to gene therapy: Lessons from commercial implementation in sickle cell disease and transfusion-dependent thalassemia was selected by the ASH Program Committee as one of the meeting’s most impactful datasets sub...

BOSTON--(BUSINESS WIRE)--PureTech’s Founded Entity Gallop Oncology Announces Positive Initial Topline Data for LYT-200 in Relapsed/Refractory Acute Myeloid Leukemia...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Encoded Therapeutics Inc., a clinical-stage biotechnology company developing genetic medicines for severe neurological disorders, today announced positive interim results from its ongoing POLARIS clinical development program evaluating ETX101 in children with SCN1A+ Dravet syndrome. The data will be featured in an oral presentation at the American Epilepsy Society (AES) Annual Meeting today and again tomorrow in a poster session. The POLARIS program...

PRINCETON, N.J.--(BUSINESS WIRE)--BMS's Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)...

BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...

BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm...