First of Multiple Planned Global Submissions for Lifileucel in 2024 and 2025 Key Step in Global Expansion to Address >20,000 Patients Annually with Previously Treated Advanced Melanoma SAN...
BMS` triplet, Iovance`s Amtagvi-Keytruda target melanoma
Strong Momentum for Amtagvi„ (Lifileucel) U.S. Launch Following U.S. Food and Drug Administration (FDA) Approval 100+ Amtagvi Patients Enrolled Across More Than 40 Current Authorized Treatment...
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,...