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. Can you share some highlights from the data presented at ASH 2023? The IND for the combination was cleared in May 2023 and we have now treated patients in the first two cohorts.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

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. In April this year, the FDA provided new feedback on the potency assays, which Iovance indicated will be addressed in the latest BLA.

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. This trial is anticipated to begin in the second half of 2023.

Food and Drug Administration 88

Food and Drug Administration Manufacturing Safety Pharmaceutical 88

Medgadget

FEBRUARY 17, 2023

Thanks to kind support from Biomed Israel , the leading international Life Science and HealthTech conference in Israel (see more below), we met with Ronan Castro, the CEO of Human Xtensions at the company’s offices in Netanya, Israel. More info can be found at the Biomed Israel website.

Physicians 80

Physicians Engineering Side effects Leads 80

Medgadget

MARCH 2, 2023

This leads to substantial damage to healthy tissues and too often results in poor outcomes. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. We hope to see Alpha TAU presenting its technology at Biomed Israel , the leading international Life Science and HealthTech conference in Israel.

Manufacturing 83

Manufacturing Leads Patients Medicine 83