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.

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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. In addition, we have received Fast Track designation by the FDA in September 2023 highlighting the impact this combination treatment can have for patients.

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Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). Most recently, Imran has served as Medical Science Liaison (MSL) Head, Oncology U.S.

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Food and Drug Administration Food Medical Medicine 110

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.

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Manufacturing Food and Drug Administration Medical science Patients 59