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The positive opinion of Keytruda was based on efficacy and safety data in more than 1,500 patients with advanced melanoma in three studies, a large Phase Ib KEYNOTE-001

Mepolizumab is delivered in a 100mg fixed dose via a subcutaneous injection every four weeks. The NDA for mepolizumab is for adults and adolescents aged 12 years or

Two patents are for HLD-200, a next-generation formulation of methylphenidate; the other patent and the NOA are for HLD-100, a next-generation formulation of amphetamine. Both products are designed

The OptimEyes trial, with FDA guidance, was designed to include a wide variety of DME patients, some of whom had no therapeutic options and were progressing to blindness.

Financial terms of the deal include the payment of $10m as follows: $5m on closing; $2m payable 6 months from closing; and, $3m payable 12 months from closing.

The agency has set a Prescription Drug User Fee Act (PDUFA) target date for mid-October this year. Dyanavel XR was developed using the company’s LiquiXR technology , which

In KTE-C19 therapy, patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell

AU-011 includes Viral-like Nanoparticles that show highly selective targeting of solid tumors while leaving normal epithelium untouched. Uveal Melanoma is an aggressive form of cancer that develops in

Aspen’s products portfolio recorded revenue of A$106m and a direct contribution to profit before tax of A$26m for the year ended 30 June 2014. To be operated under