US FDA grants accelerated approval for Iovance`s skin cancer cell therapy
SAN CARLOS, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor...
Priority Review Continues with Successful Facility Inspections Completed,no Major Review Issues FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to...
SAN CARLOS, Calif., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) today announced that its ongoing rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel is expected to be completed in the first quarter of 2023.
Today Iovance can proudly say it is not an Asco faller – but only because the poor data on its cell therapy lifileucel in melanoma, which wiped 63% off the company’s market cap in early trade today, were not actually released at the meeting.
Positive Results in Advanced Melanoma Patients, Including a 29% Objective Response Rate (ORR) in Cohort 4 of the C-144-01 Study Biologics License Application (BLA) Submission Planned for August 2022 ...
Positive FDA Feedback on Potency Assay Matrix to Support BLA Submission Further Defines Frontline Melanoma Strategy for Lifileucel in Combination with Pembrolizumab SAN CARLOS, Calif., April 05,...
SAN CARLOS, Calif., May 27, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced initial data from pivotal Cohort 4 and updated long-term data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma.
Iovance, one of the new darlings of the cancer set, pulled off the curtain raiser at ASCO with an update that adds a pair of complete responses to the mix and offers another encouraging snapshot of progress and potential for its I/O drugs.
Iovance Biotherapeutics, a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, has expanded its relationship with WuXi AppTec's Advanced Therapies Business Unit (WuXi ATU). WuXi will increase capacity for Iovance's innovaTIL-01 and innovaTIL-04 studies, which offer lifileucel and LN-145 for treatment of metastatic melanoma and recurrent, metastatic, or persistent cervical cancer, respectively.