Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

Food and Drug Administration 98

Food and Drug Administration FDA Medical science Food 98

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. When the balloon reaches a sufficient pressure, this pushes the dissolvable needle into the intestinal wall, delivering the drug payload.”

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Food and Drug Administration Manufacturing Safety Pharmaceutical 105

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.

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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. Out of 81 patients listed, having received a median of six lines of therapy, 56 suffered disease relapse while waiting for apheresis.

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Manufacturing Food and Drug Administration Medical science Patients 59