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The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded

Strensiq is the first approved treatment for HPP, an ultra-rare, genetic, metabolic disease in which patients experience devastating, progressive effects on multiple organs of the body, leading to

The NMDA receptor helps in the transfer of electrical signals between neurons in the brain and in the spinal column. Initial results from the company’s completed single ascending

It was recently approved by the U.S. Food and Drug Administration (FDA) for the once-daily, topical treatment of acne vulgaris. Epiduo Forte Gel offers patients and physicians a

Participants in the Phase 3, open-label extension study, B-YOND, maintained low bleeding rates with one to two week prophylaxis regimens, according to data from an interim analysis. Investigators

Xilonix, a novel anti-cancer agent, is being developed via a ground-breaking regulatory path that XBiotech established in collaboration with the scientific advisory committee of the European Medicines Agency

Octreotide capsules, an oral drug, are indicated for the maintenance therapy of adult patients with acromegaly. The agency has assigned a Prescription Drug User Fee Act (PDUFA) date

Conducted in collaboration with the University of Halle as sponsor and with the participation of two large leukemia study groups in Germany, the trial is aimed at evaluating

The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of 10 April 2016 for BromSite, which has a long patent life extending to August