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388,367 Results for "cell design labs".
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Press Releases
European Commission Adopts Positive Decision for Orphan Medicinal Product Designation of Agios’ Mitapivat in Sickle Cell Disease
December 19, 2024
·
8 min read
Business
Portal Biotechnologies and Multiply Labs Announce Partnership to Automate Cell Engineering In Cell Therapy Manufacturing
Multiply Labs and Portal Biotechnologies announced their collaboration today, combining the efficiency of Multiply Labs’ robotic automation with the differentiated cell engineering capabilities of the Portal platform.
May 21, 2024
·
4 min read
Press Releases
U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer
December 17, 2024
·
12 min read
Genetown
FDA Grants Orphan Drug Designation for BE-101, a Novel Engineered B Cell Medicine, for the Treatment of Hemophilia B
Be Biopharma, Inc. (“Be Bio”), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BE-101, a novel engineered B Cell medicine (BCM) being developed for the treatment of Hemophilia B.
June 4, 2024
·
4 min read
Policy
SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
SN Bioscience Co. Ltd. announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer for SNB-101, a new drug for polymer nanoparticle anticancer under clinical trial.
May 10, 2024
·
3 min read
Press Releases
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
December 9, 2024
·
10 min read
Press Releases
Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
December 9, 2024
·
9 min read
FDA
Abdera Therapeutics Announces FDA Fast Track Designation for ABD-147, a Next-Generation Precision Radiopharmaceutical Therapy, for the Treatment of Patients with Extensive-stage Small Cell Lung Cancer
Abdera Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy.
June 27, 2024
·
4 min read
Press Releases
FDA Grants Breakthrough Therapy Designation to Seres Therapeutics’ SER-155 for Reduction of Bloodstream Infections in Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT)
December 9, 2024
·
9 min read
Policy
Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer
Affimed N.V. announced that the FDA has granted Fast Track designation to the combination of its innate cell engager AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer not harboring any activating EGFR mutations after progression on PD-1 targeted therapy and platinum-based chemotherapy.
May 29, 2024
·
7 min read
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