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. We also believe that bispecifics will further establish themselves as an important drug class in the treatment regimens for both haematological malignancies and solid tumours.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

FEBRUARY 22, 2023

Biologics represent an increasingly large part of the pharmaceutical industry. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Studies show that persistence and adherence are generally better for oral medications compared with injections.

Food and Drug Administration 86

Food and Drug Administration Manufacturing Safety Pharmaceutical 86

Pharmaceutical Technology

NOVEMBER 21, 2022

Meanwhile, the drug's closest TIL competitor, Iovance Biotherapeutics’ lifileucel, has begun a rolling BLA for advanced melanoma patients and could reach the market as early as Q3 2023. The post Manufacturing challenges set back development progress of cell therapies in oncology appeared first on Pharmaceutical Technology.

Manufacturing 59

Manufacturing Food and Drug Administration Medical science Patients 59