Replimune Receives Breakthrough Therapy Designation for RP1 and Submits BLA to FDA
Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval…
Breaking News
11/22/2024
Replimune Receives Breakthrough Therapy Designation for RP1 and Submits BLA to FDA
Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval…
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06/06/2024
Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma
Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in…
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03/15/2024
The FDA Approval of TIL Therapy and What it Means for Advanced Melanoma
An exciting new development in melanoma treatment is the recent FDA approval of Lifileucel (AMTAVGI) therapy, which harnesses the power…
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03/07/2024
EXCLUSIVE WEBINAR: The FDA Approval of TIL Therapy and What it Means for Advanced Melanoma
An exciting new development in melanoma treatment is the recent FDA-approval of Lifileucel (AMTAVGI) therapy, which harnesses the power of…
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02/17/2024
Iovance Biotherapeutics Announces Approval for TIL Therapy
The Food and Drug Administration approval provides another option for advanced, refractory melanoma February 16, 2024 (Richmond, California) The FDA…
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01/18/2024
FDA Approves First AI-Powered Skin Cancer Diagnostic Tool
FDA Approves First AI-Powered Skin Cancer Diagnostic Tool The DermaSensor device demonstrates a high rate of sensitivity in the detection…
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10/23/2023
Immunocore Presents Three-Year Overall Survival Data from the KIMMTRAK Phase 3 Trial
Immunocore presents three-year overall survival data from the KIMMTRAK Phase 3 trial Published: Oct 21, 2023 Data published in New…
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10/15/2023
Opdivo® (nivolumab) Approved as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma
October 13, 2023 17:30 ET| Source: Bristol Myers Squibb In the Phase 3 CheckMate -76K trial, Opdivo demonstrated a statistically significant…
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05/30/2023
Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma
May 26, 2023 17:30 ET| Source: Iovance Biotherapeutics, Inc. Priority Review Granted with Prescription Drug User Fee Act (PDUFA) Action Date…
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02/28/2023
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma
February 28, 2023 | Source: PRINCETON, N.J.–(BUSINESS WIRE)– The applications are based on results from the Phase 3 CheckMate -76K trial,…
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