Omidria helps to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction) as well as to reduce postoperative eye pain. The company’s PharmacoSurgery product Omidria, which contains the mydriatic
The company is seeking approval for adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies
The European Commission, which has the authority to approve medicines for the European Union (EU), will now review the CHMP positive opinion. Bristol-Myers Squibb senior vice-president and head
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
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
This is the company’s third product to receive this QIDP status after WCK 771 and WCK 2349 last year further strengthening its new drug discovery program. QIDP status
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