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Aptensio XR is an extended-release formulation of methylphenidate capsule with an onset of effect of one hour and 12-hour duration of effect with about 40% of the active

A total of 2,157 patients with AHF were enrolled in the trial from over 200 centers across the US, Europe, Canada and Latin America. The TRUE-AHF Phase III

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

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.