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BeiGene's Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA -February 27, 2024 at 06:02 am EST

Application based on results from global Phase 3 RATIONALE-305 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival in advanced gastric/GEJ cancer Prescription...
United States United Kingdom Mark Lanasa Beigene Ltd End Results Program Drug Administration

BeiGene Presentations at ESMO 2023 Demonstrate Robust Clinical Strategy for Tislelizumab as Monotherapy and in Combination with Pipeline Assets

16.10.2023 - BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the presentation of promising new data showcasing BeiGene’s robust, science-driven solid tumor portfolio of commercialized and pipeline medicines ... Seite 1
Mark Lanasa Presentations Of Company European Union Drug Administration Chief Medical Officer Solid Tumors

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BeiGene Strengthens Global Portfolio and Regains Full Rights from Novartis for Anti-PD-1 Antibody TEVIMBRA® (tislelizumab)

BeiGene Strengthens Global Portfolio and Regains Full Rights from Novartis for Anti-PD-1 Antibody TEVIMBRA® (tislelizumab)Sep 19, 2023 6:00 AMRegulatory marketing applications for U.S. and EU under review, with plans to expand TEVIMBRA commercial presence worldwideTEVIMBRA is the cornerstone of BeiGene...
United States United Kingdom New Zealand Mark Lanasa Johnv Oyler European Medicines Agency

BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®

BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®Sep 19, 2023 6:15 AMEuropean Commission approves TEVIMBRA for previously treated advanced or metastatic esophageal squamous cell carcinoma (ESCC)U.S. FDA accepts Biologics License Ap...
New Zealand United Kingdom United States Mark Lanasa Josh Neiman Van Cutsem

FDA Approval Sought for Frontline Tislelizumab in Locally Advanced or Metastatic ESCC

The FDA has accepted for review a biologics license application seeking the approval of tislelizumab for use in the frontline treatment of patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma.
Mark Lanasa Solid Tumors At Beigene Ltd Map European Commission Solid Tumors Esophageal Squamous Cell Carcinoma Biologics License Application

BeiGene, Novartis Drug Alliance Ends; It's Their Second Terminated Deal This Year

BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.
United States Beigene Novartis Bristol Myers Squibb Opdivo Mark Lanasa Merck Keytruda European Commission

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