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June 30, 2016
The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.
June 24, 2016
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
June 23, 2016
The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.
June 16, 2016
Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.
June 06, 2016
The agency published a report on fostering the development of advanced therapy medicinal products.
May 06, 2016
The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.
January 29, 2016
FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.
January 21, 2016
FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.
January 12, 2016
Cell Therapy Catapult and Synpromics announced a collaboration to increase scale and efficiency of viral vector manufacturing.
January 11, 2016
Novartis enters into alliance and licensing agreement with Surface Oncology.