European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. AlloNK® is a cryopreserved, off-the-shelf, non-genetically modified, allogeneic cord blood-derived NK cell manufactured at large scale. later acquired by Eli Lilly and Company.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. ITIL-168 is an autologous TIL therapy, meaning that patients need to undergo apheresis and wait for the product to be manufactured and reinfused.

Manufacturing 59

Manufacturing Food and Drug Administration Medical science Patients 59

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Safety Pharmaceutical 84