Shorla Pharma seeks FDA approval to launch leukemia treatment
Company founders Orlaith Ryan and Sharon Cunningham. Image: Shorla Pharma
The Clonmel-headquartered biopharma start-up is preparing for the launch of its first product in the US.
Irish start-up Shorla Pharma is one step closer to launching its leukemia treatment in the US.
The company announced today (23 April) that it has submitted an application to the US Food and Drug Administration (FDA) for its oncology drug designed to treat T-cell leukemia. It is expecting that the product could be brought to market later this year.
Clonmel-headquartered Shorla Pharma was founded in 2018 by Sharon Cunningham and Orlaith Ryan, who previously worked together at EirGen Pharma in Waterford.
Shorla Pharma seeks FDA approval for oncology drug The SH-111 drug will have a significant benefit, particularly for children with leukemia
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Tipperary-based company Shorla Pharma has filed an application with the US Food and Drug Administration (FDA) to bring its specialty oncology drug designed to treat T-cell leukemia to market later this year.
The SH-111 drug is a lifesaving treatment that is often in shortage. “We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukemia,” said Sharon Cunningham, CEO and Co-founder of Shorla Pharma.
“It’s a desperately needed product and a life-changing treatment that we are honoured to bring to patients in the United States, and later, worldwide.”
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Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With a strong team of scientists, clinicians and an extensive industry network, the company has an advanced pipeline of drug products to treat a number of unmet patient needs.
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