The former commissioner pushed a regulatory pathway for rare disease drugs and launched a voucher program for expedited ...
The firm will report more data on the CAR T-cell therapy's durable efficacy later in the year and anticipates completing regulatory submissions in the fourth quarter.
The lymphoma therapy is South Korea's first home-grown CAR-T, but Curocell is also eyeing North American and European markets. The regulatory body wants public feedback on whether the definition ...
The regulatory body wants public feedback on whether the definition should be updated to comprise biological and synthetic products.
NEW YORK – Curocell and ProBio, which provides cell therapy manufacturing support to biotechs, say they're one step closer to treating lymphoma patients in South Korea with the autologous ...
The firm will be in charge of commercializing the drug in the US, where it was approved this month for treating ER-positive, HER2-negative, ESR1-mutant advanced breast cancers.
The firm announced Monday that it received authorization from regulators in the Netherlands to begin the trial.
The firm is evaluating the combination in a Phase I trial to determine if it improves responses and reduces acquired resistance.
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